SURGILENE(R) SUTURES— 510(k) K945701

Name: FDA 510(k) clearance K945701
Creator: U.S. Food and Drug Administration
Published: 1995-01-24

Substantially Equivalent for Some Indications

Davis & Geck, Inc.

FDA 510(k) clearance K945701 for SURGILENE(R) SUTURES, Substantially Equivalent for Some Indications on 1995-01-24. Applicant: Davis & Geck, Inc.. Device class: 2.

Clearance details

Applicant: Davis & Geck, Inc.
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 1994-11-09
Decision date: 1995-01-24
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.