RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP— 510(k) K943879

Substantially Equivalent

American Urologicals, Inc.

FDA 510(k) clearance K943879 for RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP, Substantially Equivalent on 1995-02-07. Applicant: American Urologicals, Inc..

Clearance details

Applicant: American Urologicals, Inc.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1994-08-09
Decision date: 1995-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.