[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: 21CFR876.5130]

[Page 366]
 
                        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 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 
gastrourological 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 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]