Submission Details
| 510(k) Number | K172537 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 22, 2017 |
| Decision Date | October 16, 2017 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
Oct 2017
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K172537 is an FDA 510(k) clearance for the Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag, 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 16, 2017, 55 days after receiving the submission on August 22, 2017. 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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