[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: 21CFR878.4350]

[Page 400]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878_GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E_Surgical Devices
 
Sec. 878.4350  Cryosurgical unit and accessories.

    (a) Identification--(1) Cryosurgical unit with a liquid nitrogen 
cooled cryoprobe and accessories. A cryosurgical unit with a liquid 
nitrogen cooled cryoprobe and accessories is a device intended to 
destroy tissue during surgical procedures by applying extreme cold.
    (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and 
accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe 
and accessories is a device intended to destroy tissue during surgical 
procedures, including urological applications, by applying extreme cold.
    (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a 
carbon dioxide dry ice applicator and accessories. A cryosurgical unit 
with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice 
applicator and accessories is a device intended to destroy tissue during 
surgical procedures by applying extreme cold. The device is intended to 
treat disease conditions such as tumors, skin cancers, acne scars, or 
hemangiomas (benign tumors consisting of newly formed blood vessels) and 
various benign or malignant gynecological conditions affecting vulvar, 
vaginal, or cervical tissue. The device is not intended for urological 
applications.
    (b) Classification. Class II.