MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT— 510(k) K042851

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K042851 for MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT, Substantially Equivalent on 2004-11-09. Applicant: Mentor Corp..

Clearance details

Applicant: Mentor Corp.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2004-10-15
Decision date: 2004-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Barbara, CA, 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.