K242073 is an FDA 510(k) clearance for the STERiJECT Ophthalmic Needle. This device is classified as a Ophthalmic Needle (Class II - Special Controls, product code QYM).
Submitted by Tsk Laboratory International Japan KK (Tochigi-Shi, JP). The FDA issued a Cleared decision on October 23, 2024, 99 days after receiving the submission on July 16, 2024.
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 | K242073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2024 |
| Decision Date | October 23, 2024 |
| Days to Decision | 99 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. |