K200325 is an FDA 510(k) clearance for the Orbit Subretinal Delivery System. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Orbit Biomedical (Ambler, US). The FDA issued a Cleared decision on July 14, 2020, 155 days after receiving the submission on February 10, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K200325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2020 |
| Decision Date | July 14, 2020 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |