510(k) K213013
K213013 is an FDA 510(k) premarket notification submitted by Jeil Tech Co., Ltd. for the device "Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe". The FDA issued a decision of Substantially Equivalent on September 19, 2022. The device falls under product code QNQ (Low Dead Space Piston Syringe), a Class II device regulated under 21 CFR 880.5860.
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.