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FDA 510(k)

ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS

K-Number: K922391 · 1992-08-18

ApplicantInstratek, Inc.
Decision Date1992-08-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Instratek, Inc.. It received FDA 510(k) clearance on 1992-08-18 under 510(k) number K922391. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS?

ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1992-08-18. The listed applicant is Instratek, Inc.. The 510(k) number is K922391.

When did ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS receive FDA 510(k) clearance?

ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS received FDA 510(k) clearance on 1992-08-18, under 510(k) number K922391.

Who is the listed applicant for ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS?

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

What is the FDA product code for ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS?

The FDA product code for ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS is HRX.

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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.

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