TSK Syringe
FDA 510(k) clearance K250127 · decided 2025-07-30
Clearance details
- K-number
- K250127
- Device name
- TSK Syringe
- Applicant
- Tsk Laboratory, Japan
- Decision
- Substantially Equivalent
- Date received
- 2025-01-17
- Decision date
- 2025-07-30
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- QNQ
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tochigi-Ken, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.