Clearance Summary
PROSAFE SAFETY SYRINGE received FDA 510(k) clearance under submission number K012726, sponsored by Hou-Se Medical, Inc.. 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 2001-10-18.
- Submission: K012726
- Applicant / Sponsor: Hou-Se Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2001-10-18
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.