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Cryo Surg 5900

by Frigitronics of Connecticut, Inc.

510(k) K840536

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 NumberK840536 Date23 Apr 1984ClearedStatusActive

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  • Withdrawn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, 21 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 Cryo Surg 5900 is a cryosurgical unit and accessory system designed to destroy tissue during surgical procedures by applying extreme cold. It utilizes a cryoprobe cooled by gases such as nitrous oxide or carbon dioxide to perform these procedures.

This device is manufactured by Frigitronics of Connecticut, Inc. and has received FDA 510(k) clearance. It is classified as a Class 2 medical device under regulation number 878.4350.

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Questions

AI-generated answers, 21 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 primary function of the Cryo Surg 5900?

    The Cryo Surg 5900 is a cryosurgical unit designed to destroy tissue during surgical procedures. It achieves this by applying extreme cold to the target area.

  • How does the device generate the cold required for surgery?

    The system utilizes a cryoprobe that is cooled by gases, specifically nitrous oxide or carbon dioxide, to facilitate the destruction of tissue.

  • What is the regulatory status of this device?

    The Cryo Surg 5900 has received FDA 510(k) clearance. It is classified as a Class 2 medical device under regulation number 878.4350.