NLE — Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed Class II
FDA product code NLE covers "Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed", a Class II medical device regulated under 21 CFR 874.4680. Submissions are reviewed by the Ear, Nose, Throat panel.
Classification Details
- Product Code
- NLE
- Device Class
- Class II
- Regulation Number
- 874.4680
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
Same as BWH except it is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).