JEK — Forceps, Biopsy, Bronchoscope (Rigid) Class II
FDA product code JEK covers "Forceps, Biopsy, Bronchoscope (Rigid)", a Class II medical device regulated under 21 CFR 874.4680. Submissions are reviewed by the Ear, Nose, Throat panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JEK
- 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).