SUPRIS RETROPUBIC SLING SYSTEM— 510(k) K111233

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K111233 for SUPRIS RETROPUBIC SLING SYSTEM, Substantially Equivalent on 2011-06-24. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2011-05-02
Decision date: 2011-06-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, 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.