Clearance Summary
RIGID ENDOSCOPE received FDA 510(k) clearance under submission number K911348, sponsored by Bruel & Kjaer. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-06-21.
- Submission: K911348
- Applicant / Sponsor: Bruel & Kjaer
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 1991-06-21
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.