NLV

Electrode, Flexible Suction Coagulator, Reprocessed

Product code: NLV
Device name: Electrode, Flexible Suction Coagulator, Reprocessed
Device class: Class 2
21 CFR: 21 CFR 876.4300
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)

FDA classification definition

The "electorde, flexible suction coagulator, reprocessed" is intended to be used endoscopically to provide simultaneous suction of fluids and coagulation of tissue. 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).

Official FDA classification page: NLV

Classification and pathway per current FDA publications. Data from openFDA (CC0).