Clearance Summary
SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES received FDA 510(k) clearance under submission number K963769, sponsored by Seirin-America, 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 1996-10-16.
- Submission: K963769
- Applicant / Sponsor: Seirin-America, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 1996-10-16
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.