NLRClass II

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

21 CFR 876.4300 / Gastroenterology, Urology

NLR is the FDA product code for Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed, a class II device type, regulated under 21 CFR 876.4300. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2003-07-03, and no recalls.

Classification record

Product code: NLR
Device name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
FDA definition: 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).
Regulation: 21 CFR 876.4300
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code NLR

By decision year

1 clearance under product code NLR with a decision year between 2003 and 2003, 2003 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NLR by decision year
Year	Clearances
2003	1

Applicants with the most clearances

Product code NLR

Applicants holding the most 510(k) clearances under product code NLR
Applicant	Clearances
Medisiss	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NLR.

Recent clearances

Product code NLR

K030919Class IISiss, Inc. (D.b.a.medisiss) Reprocessd Electrosurgical Instruments and AccessoriesMedisiss / cleared 2003-07-03

Recent recalls

Product code NLR

FDA records show no recalls under product code NLR.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)