Profile: Elcon Medical Instruments GmbH is a manufacturer and distributor of surgical instruments. Our wide range of instruments cover all surgical disciplines. We offer instruments for general surgery, gynecology, ENT surgery, cardiovascular surgery, neuro, ophthalmology, facial surgery and laparoscopy.

The company is ISO 13485:2003 certified.

FDA Registration Number: 8043816
US Agent: Dagmar Maser / Business Support International
Phone: +1-(212)-331-8358  Fax: +1-(212)-257-6441  E-Mail:

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• Ophthalmic Forceps (FDA Code: HNR / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Ophthalmic Retractor (FDA Code: HNI / 886.4350)

• Ophthalmic Suturring Needle (FDA Code: HNM / 886.4350)

• Orthopedic Elevator (FDA Code: HTE / 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.

• Orthopedic Knife (FDA Code: HTS / 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.

• Rib Rongeurs (FDA Code: HTX / 888.4540)

• Ruler and Caliper (FDA Code: FTY / 878.4800)

• Soft Ear Speculum (FDA Code: EPY / 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.

• Surgical Curette (FDA Code: FZS / 878.4800)

• Surgical Hammer (FDA Code: FZY / 878.4800)

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Stylet (FDA Code: GAH / 878.4800)

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Tonsil Knife (FDA Code: KBQ / 874.4420)

• Tonsil Snares (FDA Code: KBZ / 874.4420)

• Tonsil Suturing Needle (FDA Code: KBR / 874.4420)

• Tracheal Dilators (FDA Code: KCG / 874.4420)

• Tube Introduction Forceps (FDA Code: BWB / 868.5780) Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.

• Uterine Curettes (FDA Code: HCY / 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:

• Vaginal Retractors (FDA Code: HDL / 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:

• Wire Cutters (FDA Code: HXZ / 888.4540)

• Wire Holding Forceps (FDA Code: HYA / 878.4800)

• Wire Loop (FDA Code: JYQ / 874.4420)