FORCEPS, BIOPSY, NON-ELECTRIC— 510(k) K952863

Substantially Equivalent

Annex Medical, Inc.

FDA 510(k) clearance K952863 for FORCEPS, BIOPSY, NON-ELECTRIC, Substantially Equivalent on 1995-07-19. Applicant: Annex Medical, Inc..

Clearance details

Applicant: Annex Medical, Inc.
Product code: Code FCL
Advisory panel: Gastroenterology, Urology
Date received: 1995-06-22
Decision date: 1995-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.