FDA product code · Ear, nose and throat

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

Name: FDA decisions, review times, recalls and adverse event reports for product code NLE
Creator: 510(k) Report

NLEClass II21 CFR 874.4680510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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).

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ear, nose and throat panel

Twenty years of NLE at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — NLE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NLE? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 874.4680.

JEI Claw, Foreign Body, Bronchoscope (Non-Rigid)ENZ Telescope, Laryngeal-Bronchial JEJ Tubing, Instrumentation, Bronchoscope (Brush…BTG Brush, Biopsy, Bronchoscope (Non-Rigid)QNW Reprocessed Bronchoscope EOQ Bronchoscope (Flexible Or Rigid)JEK Forceps, Biopsy, Bronchoscope (Rigid)BST Curette, Biopsy, Bronchoscope (Non-Rigid)JEL Curette, Biopsy, Bronchoscope (Rigid)KTI Bronchoscope Accessory BWH Forceps, Biopsy, Bronchoscope (Non-Rigid)KTR Tube, Aspirating, Bronchoscope, Rigid