Profile: Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Our cardiovascular instruments includes peripheral vascular, aorta, anastomosis clamps, vascular clips and bulldog clamps, tissue and organ grasping forceps, rib and sternum retractors, valve retractors, microsurgical instruments including scissors, needle holders, forceps, ligation clips, pediatric, and sternum saw. Our columbus knee is a knee implant truly designed for use with computer assisted navigation. Our Safil® Quick is a braided absorbable suture, which provides high initial tensile strength & ultra smooth passage through tissue. Our MonoPlus® is a long-term absorbable monofilament suture made of polydioxanone. MonoPlus gives a great combination of outstanding characteristics, high tensile strength and smooth tissue passage.

The company was founded in 1977, has revenues of USD 1-5 Million, has ~120 employees.

FDA Registration Number: 2916714

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• Endoscopic Sponge Carrier (FDA Code: FGS / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Endoscopic Video Imaging System/Component (FDA Code: FET / 876.1500)

• ENT Applicator (FDA Code: KCJ / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• ENT Atomizer and Tip

• ENT Bite Block

• ENT Computer Software

• ENT Elevator (FDA Code: KAD / 874.4420)

• ENT Esophageal Dilator (FDA Code: KCF / 874.4420)

• ENT Examining/Treatment Unit (FDA Code: ETF / 874.5300) An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.

• ENT Forceps (FDA Code: KAE / 874.4420)

• ENT Irrigation Syringe (FDA Code: KCP / 874.5220)

• ENT Knife (FDA Code: KTG / 874.4420)

• ENT Manual Surgical Instrument (FDA Code: LRC / 874.4420)

• ENT Mirror (FDA Code: KAI / 874.4420)

• ENT Mobilizer (FDA Code: KAJ / 874.4420)

• ENT Nasal Gouge (FDA Code: KAQ / 874.4420)

• ENT Powder Blower (FDA Code: KCL / 874.5220)

• ENT Probe (FDA Code: KAK / 874.4420)

• ENT Punch (FDA Code: KTF / 874.4420)

• ENT Retractor (FDA Code: KAL / 874.4420)

• ENT Speculum Holder (FDA Code: KAG / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• ENT Surgical Tray (FDA Code: MMO / 874.4420)

• ENT Syringe (FDA Code: KCP / 874.5220)

• ENT Tracheal Hook (FDA Code: KCH / 874.4420)

• ENT Trocar (FDA Code: KTE / 874.4420)

• ENT Tuning Fork

• Episiotomy Scissors (FDA Code: HDK / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Epistaxis Balloon (FDA Code: EMX / 874.4100) An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.

• Esophageal Gastro-Urology Dilator (FDA Code: EZM / 876.5365) An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

• Ether Dropper (FDA Code: BTP / 868.5420) An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.

• Ether Hook (FDA Code: BTB / 868.5420)

• Ethmoid Curettes (FDA Code: KAO / 874.4420)

• Ethmoid Punch (FDA Code: KAX / 874.4420)

• External Pelvimeter (FDA Code: HER / 884.4520)

• External Vein Stripper (FDA Code: DWQ / 870.4885) An external vein stripper is an extravascular device used to remove a section of a vein.

• Eye Knife Test Drum (FDA Code: HMS / 886.4230) An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.

• Fiberoptic Light Source & Carrier (FDA Code: EQH / 874.4350) An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.

• Files (FDA Code: HTP / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Fixation Cerclage (FDA Code: JDQ / 888.3010) A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

• Fixed Size Cervical Dilator (FDA Code: HDQ / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Flavored Tongue Depressors

• Flexible/Rigid Ureteroscope and Accessories (FDA Code: FGB / 876.1500)

• Floor Standing Surgical Light (FDA Code: FSS / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Foley Catheter Holders (FDA Code: EYJ / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Forceps (FDA Code: HTD / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Forceps Needle Holders

• Forming/Cutting Instrument Clip (FDA Code: HBS / 882.4190) A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock.

• Frazier Suction Tip

• Frontal-Sinus Rasp (FDA Code: KAZ / 874.4420)

• Gallstone Scoop (FDA Code: FHL / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.