510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920747Substantially Equivalent

Pessary Flexible Silicone Donut Ring

Bioteque America Inc, Langhorne PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920747 is the FDA 510(k) clearance record for PESSARY FLEXIBLE SILICONE DONUT RING, a class II device, cleared for Bioteque America, Inc. on under FDA product code HHW (Pessary, Vaginal). FDA records list 10 510(k) clearances for Bioteque America, Inc., from to . As of , FDA records show no recalls naming K920747.

Clearance record

Decision date
Received
(922 days to decision)
Product code
HHW Pessary, Vaginal
Regulation
21 CFR 884.3575
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Bioteque America, Inc. 340 E. Maple Ave., Langhorne PA
510(k) summary
Statement
Third party review
No

Clearances, product code HHW

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