Panels › Gastroenterology, Urology

Gastroenterology, Urology devices

435 product codes reviewed by the Gastroenterology, Urology panel. 11,354 510(k) clearances and 4,428 recalls in the FDA data, 79% of those recalls name a 510(k).

240510(k)s in 12 months

323recalls in 12 months

3,512recalls that name a 510(k)

Active product codes, Class III

Code	Device	Class	510(k)s, 12 mo	Recalls, 12 mo
EZW	Stimulator, Electrical, Implantable, For Incontinence	3	0	2
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	3	0	1

Other panels: Anesthesiology · Cardiovascular · Clinical Chemistry · Clinical Toxicology · Dental · Ear, Nose, Throat · General Hospital · General, Plastic Surgery · Hematology · Immunology · Medical Genetics · Microbiology · Neurology · Obstetrics/Gynecology · Ophthalmic · Orthopedic · Pathology · Physical Medicine · Radiology