FDA product code · Gastroenterology and urology

Forceps, Biopsy, Electric, Reprocessed

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

NLUClass II21 CFR 876.4300510(k) required4 decisions since 20011 recall

4 FDA decisions since 2001. 1 recall names this code; it is not Class I.

The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k)…

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 NLU 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 · NLU

FDA has decided no NLU device since 2007.

Median 510(k) review, days · NLU

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

Recalls per year · NLU

1in 2008

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · NLU

1in 2018

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code NLU, 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	1
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	1
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in NLU? 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…NLW Electrode, Electrosurgical, Active…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

Forceps, Biopsy, Electric, Reprocessed

Which NLU devices have the deepest lineage?

What has FDA decided in NLU lately?

What has been recalled in NLU lately?

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