510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K922401Substantially Equivalent

4 Sure Tm Colostomy Pouch

Boston Pacific Medical, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922401 is the FDA 510(k) clearance record for 4 SURE TM COLOSTOMY POUCH, a class I device, cleared for Boston Pacific Medical, Inc. on under FDA product code EZQ (Pouch, Colostomy). FDA records list 11 510(k) clearances for Boston Pacific Medical, Inc., from to . As of , FDA records show no recalls naming K922401.

Clearance record

Decision date
Received
(20 days to decision)
Product code
EZQ Pouch, Colostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Boston Pacific Medical, Inc. 636 Beacon St., Boston MA
510(k) summary
Summary
Third party review
No

Clearances, product code EZQ

Trailing 12 months

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

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