Clearance Summary
E.N.S.I. RETRACTABLE SAFETY SYRINGE received FDA 510(k) clearance under submission number K003348, sponsored by Ensi-Med International Pty. , 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 2001-01-12.
- Submission: K003348
- Applicant / Sponsor: Ensi-Med International Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2001-01-12
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.