Product code NLV

Device name
Electrode, Flexible Suction Coagulator, Reprocessed
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.4300
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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).
Source
FDA openFDA device classification dataset