NLEClass II
Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed
21 CFR 874.4680 / Ear, Nose, Throat
NLE is the FDA product code for Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed, a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "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)". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- NLE
- Device name
- Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed
- FDA 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).
- Regulation
- 21 CFR 874.4680
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NLE.
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