510(k) K232943
K232943 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe". The FDA issued a decision of Substantially Equivalent on May 31, 2024. The device falls under product code QNQ (Low Dead Space Piston Syringe), a Class II device regulated under 21 CFR 880.5860. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2024
- Date Received
- September 20, 2023
- 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.