URETEX SUP PUBOURETHRAL SLING— 510(k) K012949

Substantially Equivalent

Sofradim Production

FDA 510(k) clearance K012949 for URETEX SUP PUBOURETHRAL SLING, Substantially Equivalent on 2001-10-04. Applicant: Sofradim Production.

Clearance details

Applicant: Sofradim Production
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2001-09-04
Decision date: 2001-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

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.