K060644 is an FDA 510(k) clearance for the AHMED GLAUCOMA VALVE, MODEL M4. 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 September 18, 2006, 192 days after receiving the submission on March 10, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3920.
| 510(k) Number | K060644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2006 |
| Decision Date | September 18, 2006 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| 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 |