FDA product code NLE

Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed

Ear, Nose, Throat·Class 2·21 CFR 874.4680
US regulatory classifications
US Product Code (FDA)
NLE
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 874.4680
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Medical specialty
Ear, Nose, Throat
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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).

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About this record

Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.