Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
FDA 510(k) K243149 · Congruence Medical Solutions, LLC
510(k) numberK243149
Submission
- Device name
- Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
- Applicant
- Congruence Medical Solutions, LLC
Baltimore, MD, US - Received
- September 30, 2024
- Decision date
- December 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLY – Ophthalmic Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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.
Other 510(k)s with product code QLY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)QLY · Traditional | Staclear, Inc. | 11/21/2025SE |
| K243322 | Altaviz Intravitreal SyringeQLY · Traditional | Altaviz, LLC | 05/09/2025SE |
| K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27…QLY · Traditional | Hangzhou Sightnovo Medical Technology Co., Ltd. | 04/08/2025SE |
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)QLY · Special | Staclear, Inc. | 04/03/2025SE |
| K230372 | VitreJect SyringeQLY · Traditional | Ocuject, LLC | 09/08/2023SE |
| K200242 | StaClear SyringeQLY · Traditional | Tribofilm Research, Inc. | 07/27/2020SE |
Questions and answers
When was Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) cleared by the FDA?
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (K243149) received a 510(k) decision of Substantially Equivalent on December 20, 2024, 81 days after the submission was received.
What is the product code of K243149?
The FDA product code is QLY – Ophthalmic Syringe, a Class II (moderate risk) device regulated under 21 CFR 880.5860.