510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012277Substantially Equivalent

Portex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene- Non Sterile

Abbott Medical, Hythe, Kent, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012277 is the FDA 510(k) clearance record for PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE, a class II device, cleared for Sims Portex , Ltd. on under FDA product code HHW (Pessary, Vaginal). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K012277.

Clearance record

Decision date
Received
(207 days to decision)
Product code
HHW Pessary, Vaginal
Regulation
21 CFR 884.3575
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sims Portex , Ltd. Hythe, Hythe, Kent, GB
510(k) summary
Summary
Third party review
No

Clearances, product code HHW

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