Erbe Elektromedizin GmbH

FDA Regulatory Profile

Erbe Elektromedizin GmbH has 0 FDA recalls, 1 inspection, 16 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 31, 2013 · NAI
Latest 510(k)
Jun 9, 2026

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
16
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 31, 2013Tubingen, GermanyDevicesNo Action Indicated (NAI)3002806920

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesJun 9, 2026
K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeApr 22, 2026
K253915MOVIVA® Hybrid Ablation ProbeDec 18, 2025
K251108Erbe ESU Model VIO® 3n with AccessoriesAug 29, 2025
K243120HybridAPC probeJun 20, 2025
K243451FiAPC plus probesMar 21, 2025
K242044FiAPC plus probesAug 26, 2024
K240932HybridTherm SystemAug 5, 2024
K232033HYBRIDknife® flexNov 29, 2023
K231023ERBEJET® 2 SystemJun 15, 2023
K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2…Jan 7, 2020
K191234APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC…Dec 20, 2019
K190823Erbe ESU Model VIO 3 with AccessoriesMay 22, 2019
K183445Erbe APCapplicatorsApr 4, 2019
K150364ERBE ESU Model VIO dV with AccessoriesMay 5, 2016
K934261ERBOKRYO CA CRYOSURGICAL SYSTEMApr 26, 1994