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FDA 510(k)

ERBECRYO 2 Cryosurgical Unit and Accessories

K-Number: K261806 · 2026-06-09

ApplicantErbe Elektromedizin GmbH
Decision Date2026-06-09
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBECRYO 2 Cryosurgical Unit and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K261806. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERBECRYO 2 Cryosurgical Unit and Accessories?

ERBECRYO 2 Cryosurgical Unit and Accessories is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K261806.

When did ERBECRYO 2 Cryosurgical Unit and Accessories receive FDA 510(k) clearance?

ERBECRYO 2 Cryosurgical Unit and Accessories received FDA 510(k) clearance on 2026-06-09, under 510(k) number K261806.

Who is the listed applicant for ERBECRYO 2 Cryosurgical Unit and Accessories?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERBECRYO 2 Cryosurgical Unit and Accessories?

The FDA product code for ERBECRYO 2 Cryosurgical Unit and Accessories is GEH.

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Other records listing Erbe Elektromedizin GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeK253915MOVIVA® Hybrid Ablation ProbeK251108Erbe ESU Model VIO® 3n with AccessoriesK243120HybridAPC probeK243451FiAPC plus probesK242044FiAPC plus probes

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Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.K251524Dr. Yglo Skin Tag RemoverTheotclab Healthcare B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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