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Histofreezer

by Solarcare, Inc.

510(k) K933327

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 NumberK933327 Date29 Oct 1993ClearedStatusActive

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  • Withdrawn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, 24 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 Histofreezer is a cryosurgical unit and accessory device. It is designed to facilitate cryosurgical procedures within clinical settings.

This device is authorized under FDA 510(k) number K933327. It is classified under regulation number 878.4350 for use in general and plastic surgery applications.

Other devices from Solarcare, Inc.

Questions

AI-generated answers, 24 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 clinical use of the Histofreezer?

    The Histofreezer is designed to facilitate cryosurgical procedures. It is classified under regulation number 878.4350 for use specifically within general and plastic surgery applications.

  • Is this device authorized for use in the United States?

    Yes, the Histofreezer is authorized under FDA 510(k) number K933327. This authorization confirms the device has been reviewed and cleared for clinical use.

  • What is the regulatory classification of this device?

    The device is classified as a Class 2 medical device under regulation number 878.4350, which pertains to cryosurgical units and accessories used in general and plastic surgery.