PLAIN AND CHROMIC GUT SUTURE— 510(k) K903624

Substantially Equivalent for Some Indications

Look, Inc.

FDA 510(k) clearance K903624 for PLAIN AND CHROMIC GUT SUTURE, Substantially Equivalent for Some Indications on 1990-09-18. Applicant: Look, Inc..

Clearance details

Applicant: Look, Inc.
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 1990-08-08
Decision date: 1990-09-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ada, OK, US

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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.