Clearance Summary
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES received FDA 510(k) clearance under submission number K982965, sponsored by Richard Wolf Medical Instruments Corp.. 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 1998-11-23.
- Submission: K982965
- Applicant / Sponsor: Richard Wolf Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 1998-11-23
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.