K242852 is an FDA 510(k) clearance for the ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847). This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on June 13, 2025, 266 days after receiving the submission on September 20, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K242852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2024 |
| Decision Date | June 13, 2025 |
| Days to Decision | 266 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 |