FDA 510(k)

BOJRAB MICRO-TORP, MODEL 7014-5845

K-Number: K990601 · 1999-03-31

Decision Date1999-03-31

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

BOJRAB MICRO-TORP, MODEL 7014-5845 is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 1999-03-31 under 510(k) number K990601. 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 BOJRAB MICRO-TORP, MODEL 7014-5845?

BOJRAB MICRO-TORP, MODEL 7014-5845 is a medical device that received FDA 510(k) clearance on 1999-03-31. The listed applicant is Gyrus Ent LLC. The 510(k) number is K990601.

When did BOJRAB MICRO-TORP, MODEL 7014-5845 receive FDA 510(k) clearance?

BOJRAB MICRO-TORP, MODEL 7014-5845 received FDA 510(k) clearance on 1999-03-31, under 510(k) number K990601.

Who is the listed applicant for BOJRAB MICRO-TORP, MODEL 7014-5845?

The FDA 510(k) record lists Gyrus Ent LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOJRAB MICRO-TORP, MODEL 7014-5845?

The FDA product code for BOJRAB MICRO-TORP, MODEL 7014-5845 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

View on FDA Database →

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