MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED— 510(k) K964072

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K964072 for MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED, Substantially Equivalent on 1996-12-18. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code GAN
Advisory panel: General, Plastic Surgery
Date received: 1996-10-11
Decision date: 1996-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, 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.