Clearance Summary
STERiJECT Low Dead Space, STERiJECT The Invisible Needle received FDA 510(k) clearance under submission number K231734, sponsored by Tsk Laboratory International Japan KK. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-03-08.
- Submission: K231734
- Applicant / Sponsor: Tsk Laboratory International Japan KK
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2024-03-08
Classification & Regulation
This clearance is catalogued under FDA product code QNS and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.