Clearance Summary
MODIFIED NEURO SURGERY NIBBLING FORCEPS received FDA 510(k) clearance under submission number K821357, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1982-05-14.
- Submission: K821357
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4535
- Decision date: 1982-05-14
Classification & Regulation
This clearance is catalogued under FDA product code HAO and 21 CFR 882.4535, within the Neurology review panel as a Class I device.