K992869 is an FDA 510(k) clearance for the XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 7, 1999, 43 days after receiving the submission on August 25, 1999.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K992869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1999 |
| Decision Date | October 07, 1999 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |