URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM— 510(k) K041176

Substantially Equivalent

Sofradim Production

FDA 510(k) clearance K041176 for URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM, Substantially Equivalent on 2004-05-17. Applicant: Sofradim Production.

Clearance details

Applicant: Sofradim Production
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2004-05-05
Decision date: 2004-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Ayer, MA, US

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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.