Code of Federal Regulations Title 21. Food and Drugs § 21.876.1500 Endoscope and accessories

(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories;  an endoscopic magnetic retriever intended for single use;  sterile scissors for cystoscope intended for single use;  a disposable, non-powered endoscopic grasping/cutting instrument intended for single use;  a diagnostic incandescent light source;  a fiberoptic photographic light source;  a routine fiberoptic light source;  an endoscopic sponge carrier;  a xenon arc endoscope light source;  an endoscope transformer;  an LED light source;  or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 876.9.