21 CFR § 878.4350 - Cryosurgical unit and accessories.
---
identifier: "/us/cfr/t21/s878.4350"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4350 - Cryosurgical unit and accessories."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4350"
section_name: "Cryosurgical unit and accessories."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---
# 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.