Submission Details
| 510(k) Number | K063305 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2006 |
| Decision Date | November 29, 2006 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
STIMULATING BUR GUARD
Nov 2006
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K063305 is an FDA 510(k) clearance for the STIMULATING BUR GUARD, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 29, 2006, 28 days after receiving the submission on November 1, 2006. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.
Device Classification
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.1820 |
Manufacturer
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