510(k) K213013
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2022
- Date Received
- September 20, 2021
- 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.