K881265 is an FDA 510(k) clearance for the RANEY CLIPS. This device is classified as a Clip, Scalp (Class II - Special Controls, product code HBO).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 31, 1988, 68 days after receiving the submission on March 24, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4150.
| 510(k) Number | K881265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1988 |
| Decision Date | May 31, 1988 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HBO — Clip, Scalp |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4150 |