510(k) K243149
- Device
- Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
- Applicant
- Congruence Medical Solutions, LLC
- 510(k) number
- K243149
- Product code
- QLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-20
- Date received
- 2024-09-30
- Regulation
- 880.5860
- Classification name
- Ophthalmic Syringe
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gautam Shetty
- Address
- 3000 Falls Rd. Suite 200a Baltimore MD US 21211 21211
FDA Registration Numbers#
- 3005405146
- 1064858
- 9615588
- 3012552122
- 3012478173
- 3026478941
Source Documents#
Other 510(k) Records For Product Code QLY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | 2025-11-21 |
| K243322 | Altaviz Intravitreal Syringe | Altaviz, LLC | 2025-05-09 |
| K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) | Hangzhou Sightnovo Medical Technology Co., Ltd. | 2025-04-08 |
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | 2025-04-03 |
| K230372 | VitreJect Syringe | Ocuject, LLC | 2023-09-08 |
| K200242 | StaClear Syringe | Tribofilm Research, Inc. | 2020-07-27 |