[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: 21CFR888.1100]

[Page 465]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 888--ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 888.1100  Arthroscope.


    (a) Identification. An arthroscope is an electrically powered 
endoscope intended to make visible the interior of a joint. The 
arthroscope and accessories also is intended to perform surgery within a 
joint.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the following manual arthroscopic instruments: 
cannulas, currettes, drill guides, forceps, gouges, graspers, knives, 
obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, 
suture passers, suture knotpushers, suture punches, switching rods, and 
trocars. 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. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38815, July 25, 2001]