MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System— 510(k) K171747

Clearance details

Applicant

Codman & Shurtleff, Inc.

Product code

Code HCG

Device class

Class 2

Regulation

21 CFR 882.5950

Advisory panel

Neurology

Date received

2017-06-13

Decision date

2017-07-14

Decision

Substantially Equivalent

Clearance type

Special

Location

Raynham, MA, US

• 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

• K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set2020-07-20
• K191237 — CERENOVUS Large Bore Catheter2019-11-08
• K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit2017-11-08
• K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag2017-10-16
• K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)2017-10-03

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 →