FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
K Number: K251849
·
Decision Nov 21, 2025
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
2
Review Days
158
Basic Information
- Device Name
- StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
- K Number
- K251849
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Staclear, Inc.
- Date Received
- June 16, 2025
- Decision Date
- November 21, 2025
- Product Code
- QLY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QLY | Ophthalmic Syringe | FDA class 2 | General Hospital |
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Other Clearances by Staclear, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Apr 3, 2025 | Substantially Equivalent |