Submission Details
| 510(k) Number | K120686 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 06, 2012 |
| Decision Date | April 04, 2012 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Special
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
Apr 2012
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K120686 is an FDA 510(k) clearance for the ORBIT GALAXY G2 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 April 4, 2012, 29 days after receiving the submission on March 6, 2012. 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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