MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems— 510(k) K211344

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K211344 for MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems, Substantially Equivalent on 2021-05-28. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code HCG
Advisory panel: Neurology
Date received: 2021-05-03
Decision date: 2021-05-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.