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FDA 510(k)

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe

K-Number: K253230 · 2026-04-22

ApplicantErbe Elektromedizin GmbH
Decision Date2026-04-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2026-04-22 under approval number K253230. 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; Erbe Flexible Cryoprobe?

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe is a medical device that received FDA 510(k) clearance on 2026-04-22. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K253230.

When was ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe approved by the FDA?

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe received FDA 510(k) clearance on 2026-04-22, under approval number K253230.

What company makes ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe?

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe is manufactured by Erbe Elektromedizin GmbH.

What is the FDA product code for ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe?

The FDA product code for ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe is GEH.

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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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