Clearance Summary
SCB/STERIS OR-LIGHT INTERFACE BOX received FDA 510(k) clearance under submission number K051505, 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 2005-08-11.
- Submission: K051505
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2005-08-11
Classification & Regulation
This clearance is catalogued under FDA product code FTA and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.