G-CINCH SUTURE GRASPER— 510(k) K102931

Substantially Equivalent

Usgi Medical

FDA 510(k) clearance K102931 for G-CINCH SUTURE GRASPER, Substantially Equivalent on 2010-12-30. Applicant: Usgi Medical.

Clearance details

Applicant: Usgi Medical
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2010-10-04
Decision date: 2010-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.