Clearance Summary
SONI-LOK SCOPE STABILIZER received FDA 510(k) clearance under submission number K850122, sponsored by Med Surg Designs, 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 1985-02-21.
- Submission: K850122
- Applicant / Sponsor: Med Surg Designs, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 1985-02-21
Classification & Regulation
This clearance is catalogued under FDA product code FXR and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.