COX DIAPOSABLE POLYPECTOMY SNARE— 510(k) K912254

Substantially Equivalent

Cox Medical Ent., Inc.

FDA 510(k) clearance K912254 for COX DIAPOSABLE POLYPECTOMY SNARE, Substantially Equivalent on 1991-07-26. Applicant: Cox Medical Ent., Inc..

Clearance details

Applicant: Cox Medical Ent., Inc.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 1991-05-21
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.