[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.1500]

[Page 377-378]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876_GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart B_Diagnostic Devices
 
Sec. 876.1500  Endoscope and accessories.

    (a) Identification. An endoscope and accessories is a device used to 
provide access, illumination, and allow observation or manipulation of 
body cavities, hollow organs, and canals. The device consists of various 
rigid or flexible instruments that are inserted into body spaces and may 
include an optical system for conveying an image to the user's eye and 
their accessories may assist in gaining access or increase the 
versatility and augment the capabilities of the devices. Examples of 
devices that are within this generic type of device include cleaning 
accessories for endoscopes, photographic accessories for endoscopes, 
nonpowered anoscopes, binolcular attachments for endoscopes, pocket 
battery boxes, flexible or rigid choledochoscopes, colonoscopes, 
diagnostic cystoscopes, cystourethroscopes, enteroscopes, 
esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic 
illuminators for endoscopes, incandescent endoscope lamps, biliary 
pancreatoscopes, proctoscopes, resectoscopes,

[[Page 378]]

nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic 
retrievers, cytology brushes for endoscopes, and lubricating jelly for 
transurethral surgical instruments. This section does not apply to 
endoscopes that have specialized uses in other medical specialty areas 
and that are covered by classification regulations in other parts of the 
device classification regulations.
    (b) Classification. (1) Class II (performance standards).
    (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 807of this 
chapter, subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]