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FDA 510(k)

ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM

K-Number: K933470 · 1994-03-25

ApplicantKinetix Instruments
Decision Date1994-03-25
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinetix Instruments. It received FDA 510(k) clearance on 1994-03-25 under 510(k) number K933470. 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 RELEASE SYSTEM?

ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is Kinetix Instruments. The 510(k) number is K933470.

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

ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM received FDA 510(k) clearance on 1994-03-25, under 510(k) number K933470.

Who is the listed applicant for ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM?

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

What is the FDA product code for ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM?

The FDA product code for ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM is HRX.

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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.

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