I-STOP— 510(k) K051533

Substantially Equivalent

Cl Medical

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

Clearance details

Applicant: Cl Medical
Product code: Code OTN
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

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.