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NLV — Electrode, Flexible Suction Coagulator, Reprocessed Class II

FDA Device Classification

FDA product code NLV covers "Electrode, Flexible Suction Coagulator, Reprocessed", a Class II medical device regulated under 21 CFR 876.4300. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
NLV
Device Class
Class II
Regulation Number
876.4300
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

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).

FDA data resources