GSI KNOTMAKER— 510(k) K944536

Substantially Equivalent

General Surgical Innovations

FDA 510(k) clearance K944536 for GSI KNOTMAKER, Substantially Equivalent on 1994-10-05. Applicant: General Surgical Innovations.

Clearance details

Applicant: General Surgical Innovations
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-15
Decision date: 1994-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, 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.