Clearance Summary
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 received FDA 510(k) clearance under submission number K021118, sponsored by Class A Ent.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-05-28.
- Submission: K021118
- Applicant / Sponsor: Class A Ent.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 2002-05-28
Classification & Regulation
This clearance is catalogued under FDA product code GXZ and 21 CFR 882.1350, within the Neurology review panel as a Class II device.