Clearance Summary
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM received FDA 510(k) clearance under submission number K873933, 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 1987-12-17.
- Submission: K873933
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4525
- Decision date: 1987-12-17
Classification & Regulation
This clearance is catalogued under FDA product code GZX and 21 CFR 882.4525, within the Neurology review panel as a Class I device.