AUTO SUTUREENDOSTITCH II** SUTURE APPLIER— 510(k) K972911

Name: FDA 510(k) clearance K972911
Creator: U.S. Food and Drug Administration
Published: 1998-04-25

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K972911 for AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER, Substantially Equivalent on 1998-04-25. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Product code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 1997-08-07
Decision date: 1998-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2006-10-23
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Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.