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Cryocare Surgical System

by Endocare, Inc. 2 variants

510(k) K003811

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003811 Date11 Oct 2001ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 23 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 Surgical System is a cryosurgical unit designed for use in general and plastic surgery procedures. It utilizes cryogenic technology to perform surgical treatments by freezing targeted tissues.

The system is supplied as a reusable device and is not MRI compatible. It is authorized under FDA 510K clearance with product code GEH and is manufactured by Endocare, Inc. in Irvine, California.

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

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