ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE— 510(k) K950126

Substantially Equivalent

Advanced Surgical, Inc.

FDA 510(k) clearance K950126 for ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE, Substantially Equivalent on 1995-04-13. Applicant: Advanced Surgical, Inc..

Clearance details

Applicant: Advanced Surgical, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1995-01-12
Decision date: 1995-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

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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.