Clearance Summary
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION received FDA 510(k) clearance under submission number K946332, 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 1995-06-05.
- Submission: K946332
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4140
- Decision date: 1995-06-05
Classification & Regulation
This clearance is catalogued under FDA product code EQJ and 21 CFR 874.4140, within the Ear, Nose, Throat review panel as a Class I device.