Clearance Summary
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR received FDA 510(k) clearance under submission number K842323, sponsored by American Edwards Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1984-08-17.
- Submission: K842323
- Applicant / Sponsor: American Edwards Laboratories
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1984-08-17
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.