Clearance Summary
THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM received FDA 510(k) clearance under submission number K881014, sponsored by KARL STORZ Endoscopy-America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-04-14.
- Submission: K881014
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 1988-04-14
Classification & Regulation
This clearance is catalogued under FDA product code FWF and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.