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Medi-Frig Cryosurgical Unit

by Ellman Intl., Inc.

510(k) K954703

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 NumberK954703 Date8 Feb 1996ClearedStatusActive

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  • Withdrawn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)

Full name
Medi-Frig
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, 1 Oct 2026

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

The Medi-Frig Cryosurgical Unit is a cryosurgical device designed to destroy tissue during surgical procedures by applying extreme cold. It operates using a liquid nitrogen-cooled cryoprobe and associated accessories, enabling precise freezing of targeted tissues for medical applications in general and plastic surgery.

This device is supplied as a reusable medical instrument and is classified under FDA regulation 878.4350 as a Class II cryosurgical accessory. It requires FDA 510(k) clearance (K954703) and is intended for use in controlled clinical settings. The unit is not MRI-safe and must be stored according to manufacturer guidelines to maintain functionality and sterility.

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Questions

AI-generated answers, 1 Oct 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 Medi-Frig Cryosurgical Unit used for?

    The Medi-Frig Cryosurgical Unit is designed to destroy targeted tissues during surgical procedures by applying extreme cold. It is specifically intended for use in general and plastic surgery, enabling precise freezing of tissues to achieve the desired clinical outcome.

  • How is the Medi-Frig Cryosurgical Unit supplied and what type of device is it?

    The Medi-Frig Cryosurgical Unit is supplied as a reusable medical instrument. It operates using a liquid nitrogen-cooled cryoprobe and associated accessories, making it a reusable cryosurgical accessory classified under FDA regulation 878.4350 as Class II.

  • Is the Medi-Frig Cryosurgical Unit single-use or reusable?

    The Medi-Frig Cryosurgical Unit is a reusable device. It is intended for repeated use in controlled clinical settings, provided it is maintained and stored according to the manufacturer’s guidelines to ensure functionality and sterility.

  • What are the key storage requirements for the Medi-Frig Cryosurgical Unit?

    The Medi-Frig Cryosurgical Unit must be stored according to the manufacturer’s guidelines to maintain its functionality and sterility. Proper storage ensures the device remains operational for repeated use in clinical settings.

  • Is the Medi-Frig Cryosurgical Unit MRI-safe?

    No, the Medi-Frig Cryosurgical Unit is not MRI-safe. This means it should not be used or placed in an MRI environment, as it could interfere with MRI imaging or pose a risk to patients and staff.