Clearance Summary
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES received FDA 510(k) clearance under submission number K003994, sponsored by KARL STORZ Endoscopy-America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2001-04-13.
- Submission: K003994
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 2001-04-13
Classification & Regulation
This clearance is catalogued under FDA product code ERL and 21 CFR 874.4250, within the Ear, Nose, Throat review panel as a Class II device.