NLR

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

Product code

NLR

Device name

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

Device class

Class 2

21 CFR

21 CFR 876.4300

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).