[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: 21CFR876.4370]

[Page 363-364]
 
                        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 E--Surgical Devices
 
Sec. 876.4370  Gastroenterology-urology evacuator.

    (a) Identification. A gastroenterology-urology evacuator is a device 
used to remove debris and fluids during gastroenterological and 
urological procedures by drainage, aspiration, or irrigation. This 
generic type of device includes the fluid evacuator system, manually 
powered bladder evacuator, and the AC-powered vacuum pump.
    (b) Classification. (1) Class II (special controls) for the 
gastroenterology-urology evacuator when other than manually powered. The 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to Sec. 876.9.

[[Page 364]]

    (2) Class I for the gastroenterology-urology evacuator when manually 
powered. The device subject to this paragraph (b)(2) is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 
63 FR 59228, Nov. 3, 1998]