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FDA 510(k)

GYNECOLOGICAL INSTRUMENTATION

K-Number: K895225 · 1990-03-05

ApplicantGynescope Corp.
Decision Date1990-03-05
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNECOLOGICAL INSTRUMENTATION is the device name listed in this FDA 510(k) record. The listed applicant is Gynescope Corp.. It received FDA 510(k) clearance on 1990-03-05 under 510(k) number K895225. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNECOLOGICAL INSTRUMENTATION?

GYNECOLOGICAL INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 1990-03-05. The listed applicant is Gynescope Corp.. The 510(k) number is K895225.

When did GYNECOLOGICAL INSTRUMENTATION receive FDA 510(k) clearance?

GYNECOLOGICAL INSTRUMENTATION received FDA 510(k) clearance on 1990-03-05, under 510(k) number K895225.

Who is the listed applicant for GYNECOLOGICAL INSTRUMENTATION?

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

What is the FDA product code for GYNECOLOGICAL INSTRUMENTATION?

The FDA product code for GYNECOLOGICAL INSTRUMENTATION is HET.

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Other records listing Gynescope Corp. as applicant

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Related Devices (Code: HET)

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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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