Clearance Summary
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE received FDA 510(k) clearance under submission number K912783, sponsored by Class A Ent.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1992-02-05.
- Submission: K912783
- Applicant / Sponsor: Class A Ent.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 1992-02-05
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.