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FDA 510(k)

GYNEFLEX

K-Number: K021115 · 2002-12-20

ApplicantNaissance Holdings, LC
Decision Date2002-12-20
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNEFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Naissance Holdings, LC. It received FDA 510(k) clearance on 2002-12-20 under 510(k) number K021115. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNEFLEX?

GYNEFLEX is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Naissance Holdings, LC. The 510(k) number is K021115.

When did GYNEFLEX receive FDA 510(k) clearance?

GYNEFLEX received FDA 510(k) clearance on 2002-12-20, under 510(k) number K021115.

Who is the listed applicant for GYNEFLEX?

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

What is the FDA product code for GYNEFLEX?

The FDA product code for GYNEFLEX is HIR.

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Related Devices (Code: HIR)

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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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