510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811240Substantially Equivalent

Sur-Fit Loop Ostomy o.r. Set

E. R. Squibb & Sons, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811240 is the FDA 510(k) clearance record for SUR-FIT LOOP OSTOMY O.R. SET, a class I device, cleared for E. R. Squibb & Sons, Inc. on under FDA product code EXB (Collector, Ostomy). FDA records list 32 510(k) clearances for E. R. Squibb & Sons, Inc., from to . As of , FDA records show no recalls naming K811240.

Clearance record

Decision date
Received
(43 days to decision)
Product code
EXB Collector, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
E. R. Squibb & Sons, Inc. 40 W 57th St., New York 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