FDA product code · Gastroenterology and urology

Electrode, Electrosurgical, Active, Urological, Reprocessed

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

NLWClass II21 CFR 876.4300510(k) required1 decision since 20021 recall

1 FDA decision since 2002. 1 recall names this code; it is not Class I.

The "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at…

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, gastroenterology and urology panel

Twenty years of NLW 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.

FDA decisions per year · NLW

FDA has decided no NLW device since 2007.

Median 510(k) review, days · NLW

Too few NLW 510(k)s in any year since 2007 to give a median.

Recalls per year · NLW

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NLW

1in 2025

2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code NLW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	1	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	4
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	2
2018	—	0	0
2019	—	0	1
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	1
2026	—	0	—

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

Planning a device in NLW? 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 876.4300.

FHC Adaptor To The Cord, For Transurethral…NLR Unit, Electrosurgical, Endoscopic (With Or…FBJ Cord, Electric For Transurethral Surgical…FGW Clamp, Electrical KGE Forceps, Biopsy, Electric NWI Electrosurgical Electrode Kit FHY Jelly, Contact, For Transurethral Surgical…OEK Water-Induced Thermotherapy System, Benign…KNS Unit, Electrosurgical, Endoscopic (With Or…FEH Electrode, Flexible Suction Coagulator FDI Snare, Flexible FHZ Desiccator, Transurethral

Electrode, Electrosurgical, Active, Urological, Reprocessed

Which NLW devices have the deepest lineage?

What has FDA decided in NLW lately?

What has been recalled in NLW lately?

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