Clearance Summary
VISITEC NEEDLE RANGE (GASTERUROLOGY) received FDA 510(k) clearance under submission number K811965, sponsored by Visitec Co.. 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 1981-08-25.
- Submission: K811965
- Applicant / Sponsor: Visitec Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1981-08-25
Classification & Regulation
This clearance is catalogued under FDA product code FHR and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.