PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE— 510(k) K073671

Substantially Equivalent

Ndo Surgical, Inc.

FDA 510(k) clearance K073671 for PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE, Substantially Equivalent on 2008-03-26. Applicant: Ndo Surgical, Inc..

Clearance details

Applicant: Ndo Surgical, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2007-12-27
Decision date: 2008-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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.