510(k) Report

FDA product code · Gastroenterology and urology

Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed

NLRClass II21 CFR 876.4300510(k) required1 decision since 20030 recalls

1 FDA decision since 2003. No recall names this code.

This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical 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 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, gastroenterology and urology panel

Twenty years of NLR 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 · NLR

FDA has decided no NLR device since 2007.

Median 510(k) review, days · NLR

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

Recalls per year · NLR

No recall names NLR since 2007.

Adverse event reports per year · NLR

1in 2025

2023: 12025: 1
2007high 1 (2023) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—01
20260—0—
FIG. 1 — NLR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NLR? 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

Which NLR devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K030919Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and AccessoriesMedisiss · 20032generations

What has FDA decided in NLR lately?

  • K030919Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and AccessoriesMedisiss · 2003

The one NLR decision →

Related product codes

Other codes under 21 CFR 876.4300.

FHC Adaptor To The Cord, For Transurethral…NLW Electrode, Electrosurgical, Active…FBJ Cord, Electric For Transurethral Surgical…FGW Clamp, ElectricalKGE Forceps, Biopsy, ElectricNWI Electrosurgical Electrode KitFHY Jelly, Contact, For Transurethral Surgical…OEK Water-Induced Thermotherapy System, Benign…KNS Unit, Electrosurgical, Endoscopic (With Or…FEH Electrode, Flexible Suction CoagulatorFDI Snare, FlexibleFHZ Desiccator, Transurethral