Clearance Summary
NEEDLE, ACUPUNCTURE received FDA 510(k) clearance under submission number K964051, sponsored by S-Tcm Enterprises, 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 1996-11-05.
- Submission: K964051
- Applicant / Sponsor: S-Tcm Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 1996-11-05
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.