FDA 510(k)

GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM

K-Number: K980247 · 1998-03-17

Decision Date1998-03-17

Product CodeHDC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM is the device name listed in this FDA 510(k) record. The listed applicant is Gynex Corp.. It received FDA 510(k) clearance on 1998-03-17 under 510(k) number K980247. The device is classified under product code HDC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM?

GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM is a medical device that received FDA 510(k) clearance on 1998-03-17. The listed applicant is Gynex Corp.. The 510(k) number is K980247.

When did GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM receive FDA 510(k) clearance?

GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM received FDA 510(k) clearance on 1998-03-17, under 510(k) number K980247.

Who is the listed applicant for GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM?

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

What is the FDA product code for GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM?

The FDA product code for GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM is HDC.

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Other records listing Gynex Corp. as applicant

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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.