Clearance Summary
FLEXISCOPE, MODELS 50MH AND 50 MHC received FDA 510(k) clearance under submission number K053412, sponsored by Schoelly Imaging, 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 2006-02-23.
- Submission: K053412
- Applicant / Sponsor: Schoelly Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 2006-02-23
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.