510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K844938Substantially Equivalent

United Skin Barriers

Pfizer Inc, Ny NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844938 is the FDA 510(k) clearance record for UNITED SKIN BARRIERS, a class I device, cleared for Pfizer, Inc. on under FDA product code EXB (Collector, Ostomy). FDA records list 30 510(k) clearances for Pfizer, Inc., from to . As of , FDA records show no recalls naming K844938.

Clearance record

Decision date
Received
(29 days to decision)
Product code
EXB Collector, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Pfizer, Inc. 235 E. 42nd St., Ny NY
Third party review
No

Clearances, product code EXB

Trailing 12 months

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

FDA records show no clearances under product code EXB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EXB, 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