510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K021115Substantially Equivalent

Gyneflex

Naissance Holdings, LC, Wahington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021115 is the FDA 510(k) clearance record for GYNEFLEX, a class II device, cleared for Naissance Holdings, LC on under FDA product code HIR (Perineometer). FDA records list one 510(k) clearance for Naissance Holdings, LC. As of , FDA records show no recalls naming K021115.

Clearance record

Decision date
Received
(256 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Naissance Holdings, LC 800 Connecticut Ave. NW, Wahington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIR

Trailing 12 months
1 clearance under product code HIR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260