[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: 21CFR876.4730]

[Page 357]
 
                        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. 876.4730  Manual gastroenterology-urology surgical instrument and accessories.

    (a) Identification. A manual gastroenterology-urology surgical 
instrument and accessories is a device designed to be used for 
gastroenterological and urological surgical procedures. The device may 
be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-
urology surgical instruments include the biopsy forceps cover, biopsy 
tray without biopsy instruments, line clamp, nonpowered rectal probe, 
nonelectrical clamp, colostomy spur-crushers, locking device for 
intestinal clamp, needle holder, gastro-urology hook, gastro-urology 
probe and director, nonself-retaining retractor, laparotomy rings, 
nonelectrical snare, rectal specula, bladder neck spreader, self-
retaining retractor, and scoop.
    (b) Classification. Class I (general controls). The device 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 54 FR 25049, June 12, 1989; 
66 FR 38801, July 25, 2001]