WGL ENDOSCOPIC GRASPER— 510(k) K942168

Substantially Equivalent

Wilson Greatbatch Technologies, Inc.

FDA 510(k) clearance K942168 for WGL ENDOSCOPIC GRASPER, Substantially Equivalent on 1994-12-13. Applicant: Wilson Greatbatch Technologies, Inc..

Clearance details

Applicant: Wilson Greatbatch Technologies, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1994-05-04
Decision date: 1994-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.