K211680 is an FDA 510(k) clearance for the Streamline Surgical System. This device is classified as a Pump, Infusion, Ophthalmic (Class II - Special Controls, product code MRH).
Submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on October 8, 2021, 129 days after receiving the submission on June 1, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K211680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2021 |
| Decision Date | October 08, 2021 |
| Days to Decision | 129 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 |