Submission Details
| 510(k) Number | K162437 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 2016 |
| Decision Date | October 28, 2016 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Codman EDS3 CSF External Drainage System
Oct 2016
Decision
58d
Days
Class 2
Risk
About This 510(k) Submission
K162437 is an FDA 510(k) clearance for the Codman EDS3 CSF External Drainage System, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 28, 2016, 58 days after receiving the submission on August 31, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.
Device Classification
| Product Code | JXG — Shunt, Central Nervous System And Components |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5550 |
Manufacturer
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