K902257 is an FDA 510(k) clearance for the CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II). This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on July 19, 1990, 59 days after receiving the submission on May 21, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K902257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1990 |
| Decision Date | July 19, 1990 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | JXG - Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |