MENTOR ARIS SUPRAPUBIC SURGICAL KIT— 510(k) K053296

Substantially Equivalent

Mentor Corporation

FDA 510(k) clearance K053296 for MENTOR ARIS SUPRAPUBIC SURGICAL KIT, Substantially Equivalent on 2005-12-15. Applicant: Mentor Corporation.

Clearance details

Applicant: Mentor Corporation
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2005-11-25
Decision date: 2005-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, 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.