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Cryocare Cs Surgical System

by Healthtronics 2 variants

510(k) K141110

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 NumberK141110 Date25 Jun 2015ClearedStatusActive

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  • Withdrawn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, 22 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 unit, cryosurgical, accessories device intended for use in open, minimally invasive or endoscopic surgical procedures in the areas of general surgery, plastic surgery, urology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze or ablate tissue by the application of extreme cold temperatures.

The device is supplied as a surgical system and is regulated under FDA 510(k) clearance K141110. It is classified as a Class II medical device with product code GEH and regulation number 878.4350. The system is manufactured by Healthtronics and received FDA clearance on June 25, 2015.

Other devices from HealthTronics, LLC

Questions

AI-generated answers, 22 Sep 2026

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

  • What is the Cryocare CS Surgical System intended for?

    The Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures to freeze or ablate tissue by applying extreme cold temperatures. It is designed for use in general surgery, plastic surgery, urology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery.

  • How is the Cryocare CS Surgical System supplied and what is its regulatory status?

    The device is supplied as a complete surgical system and is regulated under FDA 510(k) clearance K141110. It is classified as a Class II medical device with product code GEH and regulation number 878.4350, and received FDA clearance on June 25, 2015.

  • Who manufactures the Cryocare CS Surgical System and where is it located?

    The Cryocare CS Surgical System is manufactured by Healthtronics, located at 9825 Spectrum Dr., Bldg. 3, Austin, TX 78717, United States. The manufacturer's contact is Maritza Ward.