Clearance Summary
SMB Luer lock disposable syringe received FDA 510(k) clearance under submission number K231558, sponsored by Smb Corporation of India. 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 2024-01-12.
- Submission: K231558
- Applicant / Sponsor: Smb Corporation of India
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2024-01-12
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.