CODMAN Integrated Bipolar Cord and Tubing Set— 510(k) K163106

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K163106 for CODMAN Integrated Bipolar Cord and Tubing Set, Substantially Equivalent on 2016-12-01. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2016-11-07
Decision date: 2016-12-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.