I-STOP TRANS OBTURATOR MALE SLING— 510(k) K063079

Substantially Equivalent

Cl Medical

FDA 510(k) clearance K063079 for I-STOP TRANS OBTURATOR MALE SLING, Substantially Equivalent on 2006-11-07. Applicant: Cl Medical.

Clearance details

Applicant: Cl Medical
Product code: Code OTM
Advisory panel: General, Plastic Surgery
Date received: 2006-10-10
Decision date: 2006-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sainte Foy Les Lyon, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTM

product code OTM

Injury: 760
Total: 760

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.