AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*— 510(k) K910586

Name: FDA 510(k) clearance K910586
Creator: U.S. Food and Drug Administration
Published: 1991-03-07

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K910586 for AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*, Substantially Equivalent on 1991-03-07. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 1.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GDT
Device class: Class 1
Regulation: 21 CFR 878.4760
Advisory panel: General, Plastic Surgery
Date received: 1991-02-11
Decision date: 1991-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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K915430 — SKIN STAPLE REMOVER KIT1992-02-28
K911204 — QUALTEX SKIN STAPLE EXTRACTOR1991-05-08

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

product code GDT

Malfunction: 752
Total: 752

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.