K910938 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 August 16, 1991, 163 days after receiving the submission on March 6, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K910938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1991 |
| Decision Date | August 16, 1991 |
| Days to Decision | 163 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 |