K012124

Substantially Equivalent

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP

Applicant: Johnson & Johnson Medical (China) , Ltd.
Product code: GAP
Advisory panel: General, Plastic Surgery
Date received: 2001-07-06
Decision date: 2001-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monhang, Shanghai, CN

Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

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.