AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT— 510(k) K954231

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K954231 for AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT, Substantially Equivalent on 1995-09-22. Applicant: Promex, Inc..

Clearance details

Applicant: Promex, Inc.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1995-09-11
Decision date: 1995-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.