I-STOP— 510(k) K051533

Name: FDA 510(k) clearance K051533
Creator: U.S. Food and Drug Administration
Published: 2005-08-11

Substantially Equivalent

Cl Medical

FDA 510(k) clearance K051533 for I-STOP, Substantially Equivalent on 2005-08-11. Applicant: Cl Medical. Device class: 2.

Clearance details

Applicant: Cl Medical
Product code: Product code OTN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2005-06-09
Decision date: 2005-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sainte Foy Les Lyon, FR

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K063079 — I-STOP TRANS OBTURATOR MALE SLING2006-11-07

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.