Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GALAXY G3 Mini Microcoil Delivery System

K-Number: K171862 · 2017-09-25

ApplicantCodman & Shurtleff, Inc.
Decision Date2017-09-25
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GALAXY G3 Mini Microcoil Delivery System is a medical device manufactured by Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2017-09-25 under approval number K171862. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALAXY G3 Mini Microcoil Delivery System?

GALAXY G3 Mini Microcoil Delivery System is a medical device that received FDA 510(k) clearance on 2017-09-25. It is manufactured by Codman & Shurtleff, Inc.. The 510(k) number is K171862.

When was GALAXY G3 Mini Microcoil Delivery System approved by the FDA?

GALAXY G3 Mini Microcoil Delivery System received FDA 510(k) clearance on 2017-09-25, under approval number K171862.

What company makes GALAXY G3 Mini Microcoil Delivery System?

GALAXY G3 Mini Microcoil Delivery System is manufactured by Codman & Shurtleff, Inc..

What is the FDA product code for GALAXY G3 Mini Microcoil Delivery System?

The FDA product code for GALAXY G3 Mini Microcoil Delivery System is HCG.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT06847542 A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD RECRUITING

Other Devices by Codman & Shurtleff, Inc.

K162437Codman EDS3 CSF External Drainage System K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) K171747MICRUSFRAME 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

View all 11 devices →

Related Devices (Code: HCG)

K161367HydroCoil Embolic System (HES)MicroVention, Inc. K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. K161429Target Detachable CoilsStryker Neurovascular K153658Target Detachable CoilsStryker Neurovascular K160832Penumbra Smart CoilPenumbra, Inc. K160096InZone Detachment SystemStryker Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑