SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE— 510(k) K082828

Name: FDA 510(k) clearance K082828
Creator: U.S. Food and Drug Administration
Published: 2008-10-14

Substantially Equivalent

Suturtek Incorporated

FDA 510(k) clearance K082828 for SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE, Substantially Equivalent on 2008-10-14. Applicant: Suturtek Incorporated. Device class: 2.

Clearance details

Applicant: Suturtek Incorporated
Product code: Code GAQ
Device class: Class 2
Regulation: 21 CFR 878.4495
Advisory panel: General, Plastic Surgery
Date received: 2008-09-25
Decision date: 2008-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.