AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY— 510(k) K101444

Name: FDA 510(k) clearance K101444
Creator: U.S. Food and Drug Administration
Published: 2010-06-14

Substantially Equivalent

Surgical Devices, A Global Business Unit Tyco

FDA 510(k) clearance K101444 for AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY, Substantially Equivalent on 2010-06-14. Applicant: Surgical Devices, A Global Business Unit Tyco. Device class: 2.

Clearance details

Applicant: Surgical Devices, A Global Business Unit Tyco
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2010-05-24
Decision date: 2010-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.