NLE

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

Product code

NLE

Device name

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

Device class

Class 2

21 CFR

21 CFR 874.4680

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).