510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043480Substantially Equivalent

Enhance Clitoral Stimulation Aid

Gynavations, Inc., Malden MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K043480 is the FDA 510(k) clearance record for ENHANCE CLITORAL STIMULATION AID, a class II device, cleared for Gynavations, Inc. on under FDA product code NBV (Device, Engorgement, Clitoral). FDA records list one 510(k) clearance for Gynavations, Inc. As of , FDA records show no recalls naming K043480.

Clearance record

Decision date
Received
(174 days to decision)
Product code
NBV Device, Engorgement, Clitoral
Regulation
21 CFR 884.5970
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gynavations, Inc. 665 Salem St., Malden MA
510(k) summary
Statement
Third party review
No

Clearances, product code NBV

Trailing 12 months

FDA records hold no clearances under product code NBV in the trailing twelve months.

FDA records show no clearances under product code NBV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NBV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260