GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR— 510(k) K013718

Substantially Equivalent

Gynecare, A Div. of Ethicon, Inc.

FDA 510(k) clearance K013718 for GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR, Substantially Equivalent on 2002-01-08. Applicant: Gynecare, A Div. of Ethicon, Inc..

Clearance details

Applicant: Gynecare, A Div. of Ethicon, Inc.
Product code: Code OTO
Advisory panel: General, Plastic Surgery
Date received: 2001-11-08
Decision date: 2002-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

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.