K230372 is an FDA 510(k) clearance for the VitreJect Syringe. This device is classified as a Ophthalmic Syringe (Class II - Special Controls, product code QLY).
Submitted by Ocuject, LLC (Newport Beach, US). The FDA issued a Cleared decision on September 8, 2023, 207 days after receiving the submission on February 13, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860. An Ophthalmic Syringe Is A Piston Syringe Intended For Intraocular Injections. The Device Consists Of A Calibrated Hollow Barrel, A Movable Plunger, And May Include A Needle. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye..
| 510(k) Number | K230372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2023 |
| Decision Date | September 08, 2023 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QLY - Ophthalmic Syringe |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| Definition | An Ophthalmic Syringe Is A Piston Syringe Intended For Intraocular Injections. The Device Consists Of A Calibrated Hollow Barrel, A Movable Plunger, And May Include A Needle. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye. |