510(k) K250127
K250127 is an FDA 510(k) premarket notification submitted by Tsk Laboratory, Japan for the device "TSK Syringe". The FDA issued a decision of Substantially Equivalent on July 30, 2025. The device falls under product code QNQ (Low Dead Space Piston Syringe), a Class II device regulated under 21 CFR 880.5860. Tsk Laboratory, Japan has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2025
- Date Received
- January 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low Dead Space Piston Syringe
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.