Clearance Summary
LASER RECTOSCOPE SET 784 received FDA 510(k) clearance under submission number K842997, sponsored by Laser Industries , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1984-08-27.
- Submission: K842997
- Applicant / Sponsor: Laser Industries , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1984-08-27
Classification & Regulation
This clearance is catalogued under FDA product code FDC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.