Submission Details
| 510(k) Number | K122118 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2012 |
| Decision Date | August 03, 2012 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Special
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
Aug 2012
Decision
17d
Days
Class 2
Risk
About This 510(k) Submission
K122118 is an FDA 510(k) clearance for the HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT 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 August 3, 2012, 17 days after receiving the submission on July 17, 2012. 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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