SUTURTEK FASTCLOSE SUTURING DEVICE— 510(k) K030227

Name: FDA 510(k) clearance K030227
Creator: U.S. Food and Drug Administration
Published: 2003-03-17

Substantially Equivalent

Suturtek Incorporated

FDA 510(k) clearance K030227 for SUTURTEK FASTCLOSE SUTURING DEVICE, Substantially Equivalent on 2003-03-17. Applicant: Suturtek Incorporated. Device class: 2.

Clearance details

Applicant: Suturtek Incorporated
Product code: Code GAL
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 2003-01-22
Decision date: 2003-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkonton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.