K213173 is an FDA 510(k) clearance for the TrabEx Pro. This device is classified as a Pump, Infusion, Ophthalmic (Class II - Special Controls, product code MRH).
Submitted by Microsurgical Technologies, Inc. (Redmond, US). The FDA issued a Cleared decision on June 8, 2022, 253 days after receiving the submission on September 28, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K213173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2021 |
| Decision Date | June 08, 2022 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MRH - Pump, Infusion, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |