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

Name: FDA 510(k) clearance K211344
Creator: U.S. Food and Drug Administration
Published: 2021-05-28

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. Device class: 2.

Clearance details

Applicant: Medos International SARL
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
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 ↗

Recent devices under product code HCG

view all

K262419 — MICRUSFRAME (19+ models)2026-08-14
K261772 — Target Xtra Detachable Coil2026-06-24
K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System2026-05-20
K254221 — Optima Coil System (OptiOne Coil System)2026-01-27
K252694 — Target Detachable Coil2025-12-11

More clearances from Medos International SARL

view all

K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody2026-05-26
K260240 — SYMPHONY Navigation Ready Instruments2026-03-27
K253249 — TriALTIS Spine System2025-10-21
K243249 — TriALTIS Spine System2025-01-17
K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays2024-09-16

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.