STOMA MEASURING DEVICE— 510(k) K914482

Substantially Equivalent

Biosearch Medical Products, Inc.

FDA 510(k) clearance K914482 for STOMA MEASURING DEVICE, Substantially Equivalent on 1991-12-27. Applicant: Biosearch Medical Products, Inc..

Clearance details

Applicant: Biosearch Medical Products, Inc.
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-08
Decision date: 1991-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.