DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.— 510(k) K900198

Name: FDA 510(k) clearance K900198
Creator: U.S. Food and Drug Administration
Published: 1990-07-05

Substantially Equivalent for Some Indications

American Cyanamid Co.

FDA 510(k) clearance K900198 for DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P., Substantially Equivalent for Some Indications on 1990-07-05. Applicant: American Cyanamid Co.. Device class: 2.

Clearance details

Applicant: American Cyanamid Co.
Product code: Code GAN
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 1990-01-16
Decision date: 1990-07-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Danbury, CT, US

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Adverse events under product code GAN

product code GAN

Injury: 599
Malfunction: 1,658
Total: 2,257

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.