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