K232888 is an FDA 510(k) clearance for the Disposable Laryngeal Electrodes. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Suzhou Haishen Medical Device Associates Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 21, 2023, 94 days after receiving the submission on September 18, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K232888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2023 |
| Decision Date | December 21, 2023 |
| Days to Decision | 94 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 |