BARD IRYFIX(TM) STOMA CAP— 510(k) K862631

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K862631 for BARD IRYFIX(TM) STOMA CAP, Substantially Equivalent on 1986-10-16. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1986-07-10
Decision date: 1986-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murray Hill, NJ, US

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Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.