[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5090]

[Page 358]
 
                        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. 876.5090  Suprapubic urological catheter and accessories.

    (a) Identification. A suprapubic urological catheter and accessories 
is a flexible tubular device that is inserted through the abdominal wall 
into the urinary bladder with the aid of a trocar and cannula. The 
device is used to pass fluids to and from the urinary tract. This 
generic type of device includes the suprapubic catheter and tube, 
Malecot catheter, catheter punch instrument, suprapubic drainage tube, 
and the suprapubic cannula and trocar.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the catheter punch instrument, nondisposable cannula 
and trocar, and gastro-urological trocar. 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]