Clearance Summary
MAEDA NEW NEEDLE DISPOSABLE received FDA 510(k) clearance under submission number K000581, sponsored by Maeda Toyokichi Shoten. 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 2001-02-23.
- Submission: K000581
- Applicant / Sponsor: Maeda Toyokichi Shoten
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 2001-02-23
Classification & Regulation
This clearance is catalogued under FDA product code MQX and 21 CFR 880.5580, within the General Hospital review panel as a Class II device.