StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
FDA 510(k) clearance K251849 · decided 2025-11-21
Clearance details
- K-number
- K251849
- Device name
- StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
- Applicant
- Staclear, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-16
- Decision date
- 2025-11-21
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- QLY
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (K243149) | Congruence Medical Solutions, LLC | 2024-12-20 |
| 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.