PETERS CARDIONYL(TM) SUTURE— 510(k) K913102

Substantially Equivalent

Promedica Products, Inc.

FDA 510(k) clearance K913102 for PETERS CARDIONYL(TM) SUTURE, Substantially Equivalent on 1992-08-03. Applicant: Promedica Products, Inc..

Clearance details

Applicant: Promedica Products, Inc.
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 1991-07-12
Decision date: 1992-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

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Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.