K230951 is an FDA 510(k) clearance for the Terumo Injection Filter Needle (NF-3013RBKE05M). This device is classified as a Ophthalmic Needle (Class II - Special Controls, product code QYM).
Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on October 18, 2023, 197 days after receiving the submission on April 4, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. An Ophthalmic Needle Is A Needle Intended For Intraocular Injections. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye..
| 510(k) Number | K230951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2023 |
| Decision Date | October 18, 2023 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QYM — Ophthalmic Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| Definition | An Ophthalmic Needle Is A Needle Intended For Intraocular Injections. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye. |