[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: 21CFR876.4890]

[Page 365]
 
                        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. 876.4890  Urological table and accessories.

    (a) Identification. A urological table and accessories is a device 
that consists of a table, stirrups, and belts used to support a patient 
in a suitable position for endoscopic procedures of the lower urinary 
tract. The table can be adjusted into position manually or electrically.
    (b) Classification. (1) Class II (special controls) for the 
electrically powered urological table and accessories. The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.
    (2) Class I for the manually powered table and accessories, and for 
stirrups for electrically powered table. The device subject to this 
paragraph (b)(2) is exempt from the premarket notification procedures in 
subpart E of part 807 of 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; 63 
FR 59228, Nov. 3, 1998; 66 FR 38801, July 25, 2001]

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