K221872 is an FDA 510(k) clearance for the ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System. This device is classified as a Endoilluminator (Class II - Special Controls, product code MPA).
Submitted by Nova Eye Inc. (Business Name Nova Eye Medical) (Fremont, US). The FDA issued a Cleared decision on March 30, 2023, 275 days after receiving the submission on June 28, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K221872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2022 |
| Decision Date | March 30, 2023 |
| Days to Decision | 275 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MPA - Endoilluminator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |