[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.1500]

[Page 360-361]
 
                        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

[[Page 361]]

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, 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]