SURGIDEK B— 510(k) K943223

Name: FDA 510(k) clearance K943223
Creator: U.S. Food and Drug Administration
Published: 1994-12-05

Substantially Equivalent for Some Indications

Sutures , Ltd.

FDA 510(k) clearance K943223 for SURGIDEK B, Substantially Equivalent for Some Indications on 1994-12-05. Applicant: Sutures , Ltd.. Device class: 2.

Clearance details

Applicant: Sutures , Ltd.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 1994-07-05
Decision date: 1994-12-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ruabon, Wrexham, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.