Clearance Summary
KARL STORZ OPTICAL MEDIASTINOSCOPE received FDA 510(k) clearance under submission number K954910, 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 1995-11-03.
- Submission: K954910
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4720
- Decision date: 1995-11-03
Classification & Regulation
This clearance is catalogued under FDA product code EWY and 21 CFR 874.4720, within the Ear, Nose, Throat review panel as a Class II device.