K853770 is an FDA 510(k) clearance for the CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on October 6, 1986, 392 days after receiving the submission on September 9, 1985.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K853770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1985 |
| Decision Date | October 06, 1986 |
| Days to Decision | 392 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | GWM - Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |