ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC— 510(k) K991223

Name: FDA 510(k) clearance K991223
Creator: U.S. Food and Drug Administration
Published: 1999-04-30

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K991223 for ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC, Substantially Equivalent on 1999-04-30. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code GAL
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 1999-04-12
Decision date: 1999-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.