FDA 510(k)

MICROTEK TOTAL OSSICULAR PROTHESIS

K-Number: K895815 · 1989-12-26

Decision Date1989-12-26

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

MICROTEK TOTAL OSSICULAR PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Microbio-Medics, Inc.. It received FDA 510(k) clearance on 1989-12-26 under 510(k) number K895815. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROTEK TOTAL OSSICULAR PROTHESIS?

MICROTEK TOTAL OSSICULAR PROTHESIS is a medical device that received FDA 510(k) clearance on 1989-12-26. The listed applicant is Microbio-Medics, Inc.. The 510(k) number is K895815.

When did MICROTEK TOTAL OSSICULAR PROTHESIS receive FDA 510(k) clearance?

MICROTEK TOTAL OSSICULAR PROTHESIS received FDA 510(k) clearance on 1989-12-26, under 510(k) number K895815.

Who is the listed applicant for MICROTEK TOTAL OSSICULAR PROTHESIS?

The FDA 510(k) record lists Microbio-Medics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROTEK TOTAL OSSICULAR PROTHESIS?

The FDA product code for MICROTEK TOTAL OSSICULAR PROTHESIS is ETA.

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Related Devices (Code: ETA)

K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50MED-EL Elektromedizinische Geräte GmbH K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH K091187GRACE DYNAMIC TORPGrace Medical, Inc.K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2Audio Technologies S.R.L.K043375FISCH TITANIUM MIDDLE EAR PROSTHESESKarl Storz Endoscopy K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.