Clearance Summary
Flush Syringe (Prefilled 0.9% normal saline solution) received FDA 510(k) clearance under submission number K231724, sponsored by Spm Medicare Pvt. , Ltd.. 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 2023-11-09.
- Submission: K231724
- Applicant / Sponsor: Spm Medicare Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2023-11-09
Classification & Regulation
This clearance is catalogued under FDA product code NGT and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.