Skip to content

Cryocare CS Surgical System

by Healthtronics 2 variants

510(k) K153489

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153489 Date5 Feb 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEH
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cryocare CS Surgical System is a cryosurgical unit and accessory system designed to freeze and ablate tissue through the application of extreme cold temperatures. It is intended for use in open, minimally invasive, or endoscopic surgical procedures across various medical specialties, including general surgery, urology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery.

This device is authorized under FDA 510(k) clearance K153489. Users should refer to the operator's manual and the instructions for use for complete guidance on operation, warnings, and precautions.

Other devices from HealthTronics, LLC