Profile: Saleem Surgio (regd) provides surgical instruments for use in general surgery, obstetrics and gynecology, orthopedics, ophthalmology, and ENT surgery.
• Angiographic Injector Controller (FDA Code: DQF / 870.1670) A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal. |
• Biopsy Forceps Cover (FDA Code: FFF / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• Blood Collection Sets with Needle Holder |
• Blood Needle Holder Systems |
• Calipers (FDA Code: KTZ / 888.4150) A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis. |
• Castroviejo Curved Ophthalmic Caliper |
• Castroviejo Straight Ophthalmic Caliper |
• Circumaural Hearing Protector (FDA Code: EWE) |
• Clip Surgical Applier (FDA Code: GDO / 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. |
• Coronary Needle Holders |
• Cosmetic Surgery, Needle Holder (Serrated) |
• Crile Wood Needle Holder |
• Curved Carbide Jaw Needle Holder |
• Cystoscopic Scissors (FDA Code: KGD / 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. |
• Disposable Medical Scissors (FDA Code: JOK / 880.6820) Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors. |
• Dissecting Scalpel Blades |
• Dissecting Scalpel Handle |
• Ear Excavator (FDA Code: JYH / 874.4420) |
• Ear Scissors (FDA Code: JZB / 874.4420) |
• Ear Speculum Holder (FDA Code: JYK / 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. |
• Ear Spoon (FDA Code: JZE / 874.4420) |
• Ear Spoon & Hook |
• Ear Suction Tube (FDA Code: JZF / 874.4420) |
• 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: |
• Forceps (FDA Code: HTD / 878.4800) |
• Forceps Needle Holders |
• Forceps, Uterine Tenaculum |
• Gastroenterologic Needle Holder (FDA Code: FHQ / 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. |
• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade. |
• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800) |
• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800) |
• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800) |
• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800) |
• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800) |
• General & Plastic Surgery Surgical Rasp (FDA Code: GAC / 878.4800) |
• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800) |
• Gynecological Biopsy Forceps (FDA Code: HFB / 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: |
• Gynecological Surgical Forceps (FDA Code: HCZ / 884.4530) |
• Hemostatic Clip Applier (FDA Code: HBT / 878.4800) |
• Hexagonal Needle Holder |
• Implantable Staple (FDA Code: GDW / 878.4750) An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable. |
• Insert Hearing Protector (FDA Code: EWD) |
• Left Hand Needle Holders |
• Manual Surgical Chisel (FDA Code: FZO / 878.4800) |
• Metal Vaginal Speculum (FDA Code: HDF / 884.4520) |
• Micro Castroviejo Needle Holder with Stopper |
• Micro Needle Holder |
• Micro Needle Holder Round Handle |
• Micro Needle Holders with Flat Handles |
• Micro Needle Holders with Lightweight Plastic Handles |