Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Arthroscope (HRX) (2) Confocal Optical Imaging (OWN) (2) Endoscope, Neurological (GWG) (2) Laparoscope, General & Plastic Surgery (GCJ) (2)