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ERBE Elektromedizin GmbH: FDA-registered device maker in Rangendingen Baden-Wurttemberg, Germany, 13 510(k) clearances

Name: ERBE Elektromedizin GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ERBE Elektromedizin GmbH is registered with the FDA (registration 3009762450) in Rangendingen Baden-Wurttemberg, Germany. It lists 4 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 22, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009762450
Address: Rudolf-Diesel-Str. 29, Rangendingen Baden-Wurttemberg, Germany, 72414
Owner or operator: ERBE ELEKTROMEDIZIN GMBH (8010173)
Roles: Manufacturer
First device listed: December 6, 2007
Registered through: 2026
Brand names listed: ERBE Hybrid Knife, ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe, ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe, ERBECRYO® 2 1-pedal footswitch, ERBECRYO® 2 Cart, ERBECRYO® 2, Cryosurgical unit, ERBEJET 2 System, ERBEJET 2 two pedal footswitch and more

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Electrosurgical	JOS	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer	accessdata.fda.gov
Unit, Cryosurgical, Accessories	GEH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 22, 2026	K253230	ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe	GEH	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
December 18, 2025	K253915	MOVIVA® Hybrid Ablation Probe	GEI	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
June 20, 2025	K243120	HybridAPC probe	GEI	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
March 21, 2025	K243451	FiAPC plus probes	GEI	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
August 26, 2024	K242044	FiAPC plus probes	GEI	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
August 5, 2024	K240932	HybridTherm System	GEI	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
November 29, 2023	K232033	HYBRIDknife® flex	GEI	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
June 15, 2023	K231023	ERBEJET® 2 System	FQH	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
January 7, 2020	K190651	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	GEH	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
April 4, 2019	K183445	Erbe APCapplicators	GEI	Substantially Equivalent	Erbe Elektromedizin GmbH	accessdata.fda.gov
October 27, 2015	K143306	ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe	GEI	Substantially Equivalent	Erbe USA, Inc.	accessdata.fda.gov
August 26, 2009	K083608	ERBE HYBRID KNIFE	GEI	Substantially Equivalent	Erbe USA, Inc.	accessdata.fda.gov
October 31, 2007	K072404	ERBE ERBEJET 2 SYSTEM	FQH	Substantially Equivalent	Erbe USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.