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FDA 510(k)

ENHANCE CLITORAL STIMULATION AID

K-Number: K043480 · 2005-06-08

ApplicantGynavations, Inc.
Decision Date2005-06-08
Product CodeNBV
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENHANCE CLITORAL STIMULATION AID is the device name listed in this FDA 510(k) record. The listed applicant is Gynavations, Inc.. It received FDA 510(k) clearance on 2005-06-08 under 510(k) number K043480. The device is classified under product code NBV. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENHANCE CLITORAL STIMULATION AID?

ENHANCE CLITORAL STIMULATION AID is a medical device that received FDA 510(k) clearance on 2005-06-08. The listed applicant is Gynavations, Inc.. The 510(k) number is K043480.

When did ENHANCE CLITORAL STIMULATION AID receive FDA 510(k) clearance?

ENHANCE CLITORAL STIMULATION AID received FDA 510(k) clearance on 2005-06-08, under 510(k) number K043480.

Who is the listed applicant for ENHANCE CLITORAL STIMULATION AID?

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

What is the FDA product code for ENHANCE CLITORAL STIMULATION AID?

The FDA product code for ENHANCE CLITORAL STIMULATION AID is NBV.

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Related Devices (Code: NBV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001576EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPYProsurg, Inc.

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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