K243149 is an FDA 510(k) clearance for the Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models). This device is classified as a Ophthalmic Syringe (Class II - Special Controls, product code QLY).
Submitted by Congruence Medical Solutions, LLC (Baltimore, US). The FDA issued a Cleared decision on December 20, 2024, 81 days after receiving the submission on September 30, 2024.
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 | K243149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | December 20, 2024 |
| Days to Decision | 81 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. |