PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH— 510(k) K972412

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K972412 for PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH, Substantially Equivalent on 1997-09-10. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 1997-06-26
Decision date: 1997-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.