510(k) K231734
K231734 is an FDA 510(k) premarket notification submitted by Tsk Laboratory International Japan KK for the device "STERiJECT Low Dead Space, STERiJECT The Invisible Needle". The FDA issued a decision of Substantially Equivalent on March 8, 2024. The device falls under product code QNS (Low Dead Space Needle, Single Lumen, Hypodermic), a Class II device regulated under 21 CFR 880.5570. Tsk Laboratory International Japan KK has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2024
- Date Received
- June 14, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low Dead Space Needle, Single Lumen, Hypodermic
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.