Clearance Summary
VANDERBILT PITUITARY RETRACTOR received FDA 510(k) clearance under submission number K761096, sponsored by Codman & Shurtleff, 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 1976-11-30.
- Submission: K761096
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1976-11-30
Classification & Regulation
This clearance is catalogued under FDA product code GAD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.