K123560 is an FDA 510(k) clearance for the VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM. This device is classified as 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 January 25, 2013, 67 days after receiving the submission on November 19, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K123560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2012 |
| Decision Date | January 25, 2013 |
| Days to Decision | 67 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCG - Device, Neurovascular Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5950 |