OSTOMY BAGS COLOSTOMY— 510(k) K851679

Substantially Equivalent

Dbt Medical , Ltd.

FDA 510(k) clearance K851679 for OSTOMY BAGS COLOSTOMY, Substantially Equivalent on 1985-06-27. Applicant: Dbt Medical , Ltd..

Clearance details

Applicant: Dbt Medical , Ltd.
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1985-04-23
Decision date: 1985-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Witney,0x8 7az, GB

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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.