K955120

Substantially Equivalent

HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR

Applicant: Ethicon Endo-Surgery, Inc.
Product code: GCM
Advisory panel: Gastroenterology, Urology
Date received: 1995-11-09
Decision date: 1996-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Adverse events under product code GCM

product code GCM

Malfunction: 1,233
Total: 1,233

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.