Submission Details
| 510(k) Number | K872791 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 14, 1987 |
| Decision Date | October 20, 1987 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
Cleared
Traditional
K872791 - POREX NERVE LOCATOR
(FDA 510(k) Clearance)
Oct 1987
Decision
98d
Days
Class 2
Risk
K872791 is an FDA 510(k) clearance for the POREX NERVE LOCATOR, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on October 20, 1987, 98 days after receiving the submission on July 14, 1987. 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 |
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