Clearance Summary
MODULAR FIBERSCOPE SYSTEM received FDA 510(k) clearance under submission number K843683, sponsored by Reichert Scientific Instruments. 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 1985-01-18.
- Submission: K843683
- Applicant / Sponsor: Reichert Scientific Instruments
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1985-01-18
Classification & Regulation
This clearance is catalogued under FDA product code GCP and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.