JEI — Claw, Foreign Body, Bronchoscope (Non-Rigid) Class II
FDA product code JEI covers "Claw, Foreign Body, Bronchoscope (Non-Rigid)", a Class II medical device regulated under 21 CFR 874.4680. Submissions are reviewed by the Ear, Nose, Throat panel.
Classification Details
- Product Code
- JEI
- Device Class
- Class II
- Regulation Number
- 874.4680
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).