[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.1075]

[Page 377]
 
                        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 B_Diagnostic Devices
 
Sec. 876.1075  Gastroenterology-urology biopsy instrument.


    (a) Identification. A gastroenterology-urology biopsy instrument is 
a device used to remove, by cutting or aspiration, a specimen of tissue 
for microscopic examination. This generic type of device includes the 
biopsy punch, gastrointestinal mechanical biopsy instrument, suction 
biopsy instrument, gastro-urology biopsy needle and needle set, and 
nonelectric biopsy forceps. This section does not apply to biopsy 
instruments that have specialized uses in other medical specialty areas 
and that are covered by classification regulations in other parts of the 
device classification regulations.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the biopsy forceps cover and the non-electric biopsy 
forceps. 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]