K230975 is an FDA 510(k) clearance for the Ahmed® Glaucoma Valve Model FP7. This device is classified as a Implant, Eye Valve (Class II - Special Controls, product code KYF).
Submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 12, 2023, 37 days after receiving the submission on April 5, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3920.
| 510(k) Number | K230975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2023 |
| Decision Date | May 12, 2023 |
| Days to Decision | 37 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYF - Implant, Eye Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3920 |