CMS Oncoprobe

No FDA recalls on record, checked 22 Oct 2026.

Full name

Cms Oncoprobe (Tm)

510(k) Number

K904421 ↗

FDA Product Code

GEH

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cms Urethral Warmer

  Class II

  FDA 510(k) K952895 Active Cleared 24 Oct 1995

• Cms Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722

  Class II

  FDA 510(k) K980670 Active Cleared 17 Jul 1998

• Cms Blizzard 700 Series Models 730, 740, 750, 760, 770, 780 & 790

  Class II

  FDA 510(k) K980668 Active Cleared 17 Jul 1998

• Cms Accuprobe 550/530

  Class II

  FDA 510(k) K953637 Active Cleared 4 Dec 1995

• Cms Accuprobe 610, 620, 630, 640, 650, 660, 670, 680

  Class II

  FDA 510(k) K964336 Active Cleared 20 Mar 1997

• Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880

  Class II

  FDA 510(k) K982055 Active Cleared 8 Sep 1998

See all devices from Cryomedical Sciences, Inc. →

• What types of medical procedures is the CMS Oncoprobe primarily used for, and why is it considered suitable for these applications?

  The CMS Oncoprobe is designed for controlled cryoablation procedures, which are typically used in general and plastic surgery to destroy or preserve tissue through precise freezing. It is particularly suited for applications where targeted tissue destruction—such as tumor removal or skin lesion treatment—requires controlled cryogenic temperatures. Its classification as a cryosurgical accessory and FDA 510(k) clearance (K904421) under the General, Plastic Surgery advisory committee indicate its regulatory alignment with these surgical specialties.

• Is the CMS Oncoprobe single-use or reusable, and what does this mean for its maintenance and sterilization?

  The CMS Oncoprobe is explicitly described as a reusable device, meaning it is intended for repeated use after proper cleaning and sterilization. Since it is not labeled as single-use, it must be maintained in a sterile environment for each procedure, adhering to standard surgical instrument reprocessing protocols. The manufacturer’s regulatory data does not specify additional sterility requirements beyond general surgical standards, so facilities must follow established decontamination and sterilization procedures.

• How do I determine if a specific CMS Oncoprobe model is compatible with my facility’s cryosurgical system?

  The CMS Oncoprobe is part of a family of cryosurgical tools, and compatibility depends on the specific model and your facility’s cryogenic delivery system. While the provided data lists multiple registration numbers (e.g., 3010242262, 3003678543), these are administrative identifiers—not model specifications. To confirm compatibility, consult the manufacturer’s technical documentation or contact Cryomedical Sciences, Inc. directly, as they can provide details on model variations, connectors, and system requirements for seamless integration.

• Can the CMS Oncoprobe be used in an MRI environment, and what safety precautions should be taken?

  The CMS Oncoprobe is not MRI-safe, meaning it should never be used or stored in an MRI environment. This is explicitly noted in the regulatory data, as metallic or cryogenic components could pose risks to MRI equipment or patient safety. If MRI compatibility is required, alternative cryosurgical tools must be selected, and strict protocols for non-MRI environments must be followed, including proper labeling and segregation of the device.

• What does the FDA 510(k) clearance (K904421) indicate about the CMS Oncoprobe’s regulatory status, and how does this affect its use?

  The FDA 510(k) clearance (K904421) confirms that the CMS Oncoprobe is substantially equivalent to a legally marketed predicate device, meeting FDA standards for safety and effectiveness as a Class II cryosurgical accessory. This clearance does not imply any specific clinical indication but rather validates its design and performance for controlled cryoablation in sterile surgical settings, as outlined in its intended use. Clinicians and facilities should ensure compliance with FDA guidelines and institutional protocols when incorporating the device into procedures.