4 SURE TM COLOSTOMY POUCH— 510(k) K922401

Substantially Equivalent

Boston Pacific Medical, Inc.

FDA 510(k) clearance K922401 for 4 SURE TM COLOSTOMY POUCH, Substantially Equivalent on 1992-06-10. Applicant: Boston Pacific Medical, Inc..

Clearance details

Applicant: Boston Pacific Medical, Inc.
Product code: Code EZQ
Advisory panel: Gastroenterology, Urology
Date received: 1992-05-21
Decision date: 1992-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZQ

product code EZQ

Malfunction: 800
Other: 1
Total: 801

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.