Submission Details
| 510(k) Number | K171862 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 22, 2017 |
| Decision Date | September 25, 2017 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
GALAXY G3 Mini Microcoil Delivery System
Sep 2017
Decision
95d
Days
Class 2
Risk
About This 510(k) Submission
K171862 is an FDA 510(k) clearance for the GALAXY G3 Mini Microcoil Delivery System, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on September 25, 2017, 95 days after receiving the submission on June 22, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.
Device Classification
| Product Code | HCG — Device, Neurovascular Embolization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5950 |
Manufacturer
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