FDA 510(k)

RICHARDS TORP

K-Number: K952549 · 1995-07-03

Decision Date1995-07-03

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

RICHARDS TORP is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1995-07-03 under 510(k) number K952549. 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 RICHARDS TORP?

RICHARDS TORP is a medical device that received FDA 510(k) clearance on 1995-07-03. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K952549.

When did RICHARDS TORP receive FDA 510(k) clearance?

RICHARDS TORP received FDA 510(k) clearance on 1995-07-03, under 510(k) number K952549.

Who is the listed applicant for RICHARDS TORP?

The FDA 510(k) record lists Smith & Nephew Richards, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RICHARDS TORP?

The FDA product code for RICHARDS TORP is ETA.

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Other records listing Smith & Nephew Richards, Inc. as applicant

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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.