Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
FDA 510(k) clearance K243149 · decided 2024-12-20
Clearance details
- K-number
- K243149
- Device name
- Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
- Applicant
- Congruence Medical Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-09-30
- Decision date
- 2024-12-20
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- QLY
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Congruence Medical Solutions
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (K251849) | Staclear, Inc. | 2025-11-21 |
| Altaviz Intravitreal Syringe (K243322) | Altaviz, LLC | 2025-05-09 |
| Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) (K243027) | Hangzhou Sightnovo Medical Technology Co., Ltd. | 2025-04-08 |
| StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (K243936) | Staclear, Inc. | 2025-04-03 |
| VitreJect Syringe (K230372) | Ocuject, LLC | 2023-09-08 |
| StaClear Syringe (K200242) | Tribofilm Research, Inc. | 2020-07-27 |
Recalls involving this device
No recalls on record reference this clearance.