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

Name: FDA 510(k) clearance K073671
Creator: U.S. Food and Drug Administration
Published: 2008-03-26

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.. Device class: 2.

Clearance details

Applicant: Ndo Surgical, Inc.
Product code: Code OCW
Device class: Class 2
Regulation: 21 CFR 876.1500
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 ↗

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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.