K092577

Substantially Equivalent

ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)

Applicant: Ethicon Endo-Surgery, LLC
Product code: GDW
Advisory panel: General, Plastic Surgery
Date received: 2009-08-21
Decision date: 2009-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.