ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
Device Facts
| Record ID | K253230 |
|---|---|
| Device Name | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe |
| Applicant | Erbe Elektromedizin GmbH |
| Product Code | GEH · General, Plastic Surgery |
| Decision Date | Apr 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4350 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K253230 · Apr 22, 2026 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH | Peer-reviewed clinical literature; Randomized controlled trial (RCT) | The sponsor provided peer-reviewed literature and an RCT to support the safety and effectiveness of the elongated flexible cryoprobe variant for use in the GI tract. | GI tract application; Safety and effectiveness; Elongated probe |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Peer-reviewed literature (including randomized controlled trial); Randomized controlled trial and peer-reviewed clinical literature | Patients undergoing interventional procedures in the GI tract | Not applicable for this study | Safety and effectiveness of the elongated cryoprobe |
Indications for Use
The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization (destruction) of tissue by the application of extreme cold. The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
Device Story
ERBECRYO 2 is a cryosurgical unit consisting of a steel/aluminum housing, user interface, and gas control module; it connects to a CO2 source, footswitch, and flexible cryoprobes. The system operates via the Joule-Thomson effect, delivering regulated CO2 flow to the probe tip to achieve extreme cold. Used in clinical settings by physicians for interventional procedures (e.g., GI tract). The device enables cryoadhesion for tissue removal or devitalization. The subject device introduces an elongated flexible cryoprobe (2550mm) compared to the predicate (1150mm). The provider uses the probe under endoscopic guidance to target tissue; the resulting cryo-effect allows for biopsy or recanalization. Benefits include improved reach for GI applications while maintaining the same safety profile as the predicate.
Clinical Evidence
Bench testing included side-by-side tissue freezing performance comparisons, sterilization validation (ISO 11135, SAL 10^-6), EO residual testing (ISO 10993-7), biocompatibility (ISO 10993-1), packaging/shelf-life (ISO 11607-1, ASTM F 1980), EMC (IEC 60601-1-2), and electrical safety (IEC 60601-1). Real-world evidence, including a randomized controlled trial, was provided to support the safety and effectiveness of the elongated probe for GI tract applications.
Technological Characteristics
Materials: stainless steel, silicone, plastics. Energy: CO2 gas (Joule-Thomson effect). Input pressure: 769-943 psi. Connectivity: footswitch, ECB (Erbe communication bus). Sterilization: Ethylene Oxide. Software: IEC 62304 compliant. Dimensions: 1.7mm OD, 2550mm length.
Indications for Use
Indicated for palliative tissue devitalization and cryoadhesion during interventional procedures, including removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tumors (palliative recanalization), and tissue biopsies.
Regulatory Classification
Identification
(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.
Predicate Devices
- ERBECRYO 2 Cryosurgical Unit and Accessories (K190651)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 22, 2026
Erbe Elektromedizin GmbH
Matthias Kollek
Regulatory Affairs Specialist
Waldhoernlestrasse 17
Tuebingen, 72072
Germany
Re: K253230
Trade/Device Name: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
Regulation Number: 21 CFR 878.4350
Regulation Name: Cryosurgical Unit And Accessories
Regulatory Class: Class II
Product Code: GEH
Dated: September 29, 2025
Received: March 19, 2026
Dear Matthias Kollek:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253230 - Matthias Kollek
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253230 - Matthias Kollek
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin K. Chen -S
Digitally signed by Colin
K. Chen -S
Date: 2026.04.22
21:59:05 -04'00"
Colin K. Chen, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K253230 | ? |
| Please provide the device trade name(s). | | ? |
| ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible
Cryoprobe | | |
| Please provide your Indications for Use below. | | ? |
| Indications for Use statement for the ERBECRYO 2 cryosurgical unit:
The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization
(destruction) of tissue by the application of extreme cold.
Indications for Use statement for the Erbe Flexible Cryoprobes:
The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during
interventional procedures by the application of extreme cold and cryoadhesion for applications such as the
removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization)
and tissue biopsies. | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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Erbe Elektromedizin GmbH
K253230 - Traditional 510(k) for Flexible Cryoprobe
# 510(k) SUMMARY
## Applicant
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
72072 Tuebingen
Germany
Tel: 0049-7071-755-0
Fax: 0049-7071-755-179
## Contact Person
Dr. Matthias Kollek
Regulatory Affairs Specialist
E-Mail: Matthias.Kollek@erbe-med.com
## Date Prepared
April 21, 2026
## Device Information
Trade/Proprietary Name: ERBECRYO 2 Cryosurgical Unit and Accessories; Erbe Flexible Cryoprobes
Common Name: Cryosurgical Unit; Endoscopic cryosurgical probe
Classification Name: Cryosurgical Unit & Accessories
Regulation Number: 21 CFR 878.4350
Class: II
Product Code: GEH
## Legally Marketed Predicate Devices
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651
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Erbe Elektromedizin GmbH
K253230 - Traditional 510(k) for Flexible Cryoprobe
## Device Description
The ERBECRYO 2 unit consists of a steel casing with an aluminum casing button. The plastic face frame comprises the power switch, a plastic receptacle, and a LED display with a membrane keypad. Inside the housing the hardware components are installed. These are the electrical mains supply, the main board (central control unit), the user interface, the gas flow and control module, the flow sensor module and connection sockets for the Flexible Cryoprobes, the footswitch and ECB (Erbe communication bus).
The Unit is connected to an electrical power source, a Carbon Dioxide (CO₂) source, the footswitch, and an instrument. Upon activation via the pedal of the footswitch, the Unit delivers the regulated CO₂ flow to the end of the connected instrument.
The Flexible Cryoprobes are sterile, single-use flexible probes that are connected to the parent device ERBECRYO 2 for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies in combination with a cryosurgical unit.
## Device Modification
Compared to the initial clearance (K190651), an elongated variant of the Flexible Cryoprobes is added. The new variant has the same materials, operating principle, and fundamental design as the already cleared variants. The only difference is a longer distal end.
## Indications for Use
The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
## Comparison of Technological Characteristics
### ERBECRYO 2
Besides labeling changes due to updated risk management (not related to the elongated cryoprobe), there were no changes to the design, operating principle, software or performance specifications of the parent device ERBECRYO 2 compared to the last clearance K190651.
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Erbe Elektromedizin GmbH
K253230 - Traditional 510(k) for Flexible Cryoprobe
Flexible Cryoprobes
| Characteristics | Subject Device | | | Predicate Device | | | Comparison |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Flexible Cryoprobe | | | Flexible Cryoprobes K190651 | | | |
| Manufacturer | Erbe Elektromedizin GmbH (Germany) | | | Erbe Elektromedizin GmbH (Germany) | | | Same |
| Regulation number | 878.4350 | | | 878.4350 | | | Same |
| Regulatory class | II | | | II | | | Same |
| Product code | GEH | | | GEH | | | Same |
| Indications for use | The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies. | | | The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies. | | | Same |
| Prescription or OTC | Prescription | | | Prescription | | | Same |
| Compatibility | ERBECRYO 2 | | | ERBECRYO 2 | | | Same |
| Materials | Stainless steel, silicone, plastics, printing color, adhesive | | | Stainless steel, silicone, plastics, printing color, adhesive | | | Same |
| Probe Dimensions | OD [mm] | Length [mm] | Over-sheath | OD [mm] | Length [mm] | Over-sheath | Increased length based on cleared probe with OD of 1.7mm. |
| | 1.7 | 2550 | N/A | 1.1 | 1150 | OD 2.6mm L 817mm | |
| | | | | 1.1 | 1150 | OD 2.6mm L 757mm | |
| | | | | 1.7 | 1150 | N/A | |
| | | | | 2.4 | 1150 | N/A | |
| | | | | 2.4 | 1150 | N/A | |
| Input pressure | 769 psi to 943 psi (53 bar to 65 bar) | | | 769 psi to 943 psi (53 bar to 65 bar) | | | Same |
| Energy delivery | Cooling by means of CO₂ (Joule-Thomson Effect) | | | Cooling by means of CO₂ (Joule-Thomson Effect) | | | Same |
| Condition Provided/Use Condition | Sterile, single-use | | | Sterile, single-use | | | Same |
| Shelf-life | 3 years | | | 3 years | | | |
| Sterilization Method | Ethylene Oxide | | | Ethylene Oxide | | | Same |
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Erbe Elektromedizin GmbH
K253230 - Traditional 510(k) for Flexible Cryoprobe
The modified Flexible Cryoprobe is based on the cleared variant with an OD of 1.7mm. Compared to the cleared variant, the only difference is an increased distal length (Modified device: 2550mm compared to cleared device: 1150mm). All other technological characteristics such as materials, operating principle, energy type and fundamental design are identical. The modified and cleared probe variants have the same intended use. Non-clinical bench performance testing and safety considerations as described below demonstrate that the modified and cleared probe variants are substantially equivalent.
## Safety Considerations
Due to the length disparity between the subject and the predicate device, a benefit-risk discussion was provided in compliance with FDA Guidance "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics", demonstrating an improved benefit-risk profile (partially improved benefits while sharing the same risks) compared to the predicate device for the anticipated use in the GI tract.
To substantiate the anticipated application in the GI tract, real-world evidence in form of peer reviewed literature including a randomized controlled trial was provided to demonstrate safety and effectiveness of the elongated probe.
## Summary of non-clinical bench performance testing
Functional testing and design controls to verify both safety and performance of the subject device based on the risk analysis according to ISO 14971 was performed in compliance with ISO 13485, clause 7.3 to ensure that the subject device performs as intended and meets design specifications.
Side-by-side tissue testing was conducted to demonstrate equivalent freezing performance of the subject device compared to the predicate device by measuring the mean biopsy size in a standardized ex vivo setup including common activation times for cryoprobes and the simulation of the application conditions in the human body. Testing was performed on different tissue types to cover a range of tissue densities.
Sterilization validation was performed in compliance with ISO 11135 showing an SAL of 10-6. EO residual testing and limits are in compliance with ISO 10993-7.
Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to demonstrate biocompatibility of the used materials.
Packaging and shelf-life validation was performed in compliance with ISO 11607-1 and accelerated aged (ASTM F 1980) devices.
Electromagnetic compatibility (EMC) was tested in compliance with IEC 60601-1-2 and FDA
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Erbe Elektromedizin GmbH
K253230 - Traditional 510(k) for Flexible Cryoprobe
Guidance "Electromagnetic Compatibility (EMC) of Medical Devices".
Electrical safety was tested in compliance with IEC 60601-1.
Software verification was provided for an enhanced documentation level in compliance with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions" and the device complies with FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
# Conclusion
The subject device has the same intended use, the same fundamental design, substantially equivalent performance characteristics, and the same energy source as the predicate device. The subject device was tested as described above to demonstrate reasonable assurance of safety and effectiveness of the elongated cryoprobe. Taken together, the subject device does not raise new or different questions of safety and effectiveness, and the subject device is substantially equivalent to the predicate device.
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