Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range— 510(k) K171040

Substantially Equivalent

Koelis

FDA 510(k) clearance K171040 for Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range, Substantially Equivalent on 2017-07-31. Applicant: Koelis.

Clearance details

Applicant: Koelis
Product code: Code ITX
Advisory panel: Radiology
Date received: 2017-04-06
Decision date: 2017-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Meylan, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.