Clearance Summary
BIOMATE STERILE ACUPUNCTURE NEEDLE received FDA 510(k) clearance under submission number K103061, sponsored by Biomate Medical Devices Technology Co., 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 2011-06-20.
- Submission: K103061
- Applicant / Sponsor: Biomate Medical Devices Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 2011-06-20
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.