[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5130]

[Page 352-353]
 
                        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 F--Therapeutic Devices
 
Sec. 876.5130  Urological catheter and accessories.

    (a) Identification. A urological catheter and accessories is a 
flexible tubular device that is inserted through the urethra and used to 
pass fluids to or

[[Page 353]]

from the urinary tract. This generic type of device includes radiopaque 
urological catheters, ureteral catheters, urethral catheters, coude 
catheters, balloon retention type catheters, straight catheters, upper 
urinary tract catheters, double lumen female urethrographic catheters, 
disposable ureteral catheters, male urethrographic catheters, and 
urological catheter accessories including ureteral catheter stylets, 
ureteral catheter adapters, ureteral catheter holders, ureteral catheter 
stylets, ureteral catheterization trays, and the gastro-urological 
irrigation tray (for urological use).
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the ureteral stylet (guidewire), stylet for gastro-
urological catheter, ureteral catheter adapter, ureteral catheter 
connector, and ureteral catheter holder. The devices subject to this 
paragraph (b)(2) are exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]