DAWN DISPOSABLE BIOPSY FORCEPS— 510(k) K933135

Substantially Equivalent

Dawn Medical

FDA 510(k) clearance K933135 for DAWN DISPOSABLE BIOPSY FORCEPS, Substantially Equivalent on 1994-03-07. Applicant: Dawn Medical.

Clearance details

Applicant: Dawn Medical
Product code: Code FCL
Advisory panel: Gastroenterology, Urology
Date received: 1993-06-28
Decision date: 1994-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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.