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CS-76 And/Or Cryocare I

by Frigitronics of Connecticut, Inc.

510(k) K760742

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 NumberK760742 Date3 Nov 1976ClearedStatusActive

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  • Withdrawn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 CS-76 And/Or Cryocare I is a cryosurgical unit and accessory system designed for medical procedures. This non-electric, self-pressurizing system utilizes liquid nitrogen to perform cryosurgical applications.

The device is supplied with two built-in stainless steel canisters, each featuring a 1-liter capacity, and is mounted on a four-wheel roller stand. It is classified as a Class 2 medical device under FDA regulation 878.4350. This system received FDA 510(k) clearance under the number K760742.

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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 CS-76 And/Or Cryocare I used for?

    This device is a cryosurgical unit designed for performing cryosurgical applications in medical procedures.

  • How is the system powered and operated?

    The system is non-electric and self-pressurizing. It operates by utilizing liquid nitrogen to perform its cryosurgical functions.

  • What are the physical specifications of the unit?

    The device is supplied with two built-in stainless steel canisters, each with a 1-liter capacity. The entire system is mounted on a four-wheel roller stand for mobility.

  • What is the regulatory status of this device?

    The CS-76 And/Or Cryocare I is classified as a Class 2 medical device under FDA regulation 878.4350 and received FDA 510(k) clearance under the number K760742.