[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: 21CFR884.1700]

[Page 432]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1700  Hysteroscopic insufflator.

    (a) Identification. A hysteroscopic insufflator is a device designed 
to distend the uterus by filling the uterine cavity with a liquid or gas 
to facilitate viewing with a hysteroscope.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for tubing and tubing/filter fits which only include 
accessory instruments that are not used to effect intrauterine access, 
e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits 
used for only intrauterine insufflation. 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. 884.9.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 
1996; 66 FR 38808, July 25, 2001]