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Data / Medical devices / Germany / Erbe Elektromedizin GMBH

Erbe Elektromedizin GMBH: FDA-registered device maker in TUEBINGEN Baden-Wurttemberg, Germany, 34 510(k) clearances

Erbe Elektromedizin GMBH is registered with the FDA (registration 9610614) in TUEBINGEN Baden-Wurttemberg, Germany. It lists 9 device types. The FDA files 34 510(k) clearances under its listings, the newest dated June 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Erbe Elektromedizin GMBH
FDA registration number
9610614
FEI number
3002806920
Address
Waldhoernlestrasse 17, TUEBINGEN Baden-Wurttemberg, Germany, 72072
Owner or operator
ERBE ELEKTROMEDIZIN GMBH (8010173)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
December 6, 2005
Registered through
2026
Brand names listed
APC 2 and Accessories, APC 3 Argon Plasma Coagulation Unit, APC Applicators, APC Integrated Filter Probes, APC Pressure Reducer w/Sensor, APC Probes, APCapplicators, Accessories for ERBE ESUs and more

Devices it lists

DeviceProduct codeClassRoleSource
Electrode, ElectrosurgicalJOS2Manufactureraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufacturer, Specification developeraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Specification developeraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Specification developeraccessdata.fda.gov
Lavage, JetFQH2Manufacturer, Specification developeraccessdata.fda.gov
ResectoscopeFJL2Contract manufactureraccessdata.fda.gov
Resectoscope, Working ElementFDC2Contract manufactureraccessdata.fda.gov
Unit, Cryosurgical, AccessoriesGEH2Manufacturer, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 9, 2026K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesGEHSubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
April 22, 2026K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeGEHSubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
December 18, 2025K253915MOVIVA® Hybrid Ablation ProbeGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
August 29, 2025K251108Erbe ESU Model VIO® 3n with AccessoriesGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
June 20, 2025K243120HybridAPC probeGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
March 21, 2025K243451FiAPC plus probesGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
August 26, 2024K242044FiAPC plus probesGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
August 5, 2024K240932HybridTherm SystemGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
November 29, 2023K232033HYBRIDknife® flexGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
June 15, 2023K231023ERBEJET® 2 SystemFQHSubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
January 7, 2020K190651ERBECRYO 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, adapterGEHSubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
December 20, 2019K191234APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening setsGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
May 22, 2019K190823Erbe ESU Model VIO 3 with AccessoriesGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
April 4, 2019K183445Erbe APCapplicatorsGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
May 5, 2016K150364ERBE ESU Model VIO dV with AccessoriesGEISubstantially EquivalentErbe Elektromedizin GmbHaccessdata.fda.gov
October 27, 2015K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
December 11, 2013K133180ERBE ESU MODEL VIO DV WITH ACCESSORIESGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
December 23, 2010K103235ERBEFLO 2 DISPOSABLE TUBING SYSTEMOCXSubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
July 16, 2010K101108ERBE ESU MODEL VIO 100 C WITH ACCESSORIESGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
November 30, 2009K092090ERBELIFT HAND PUMP AND FLEXIBLE PROBEFBKSubstantially EquivalentByrne Medical, Inc.accessdata.fda.gov
August 26, 2009K083608ERBE HYBRID KNIFEGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
December 31, 2008K083452ERBE MODEL VIO 300 D WITH ACCESSORIESGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
April 2, 2008K080715ERBE VIO ESU, MODEL VIO 200 SGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
October 31, 2007K072404ERBE ERBEJET 2 SYSTEMFQHSubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
March 16, 2006K060484ERBE VIO ESU, MODEL VIO 300 DGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
February 16, 2006K060183ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTERGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
January 8, 2003K024047ERBE VIO APC WITH ACCESSORIESGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
December 12, 2002K023886ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 DGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
November 29, 2002K023812NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085GEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
October 26, 2001K013348MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166GEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
January 4, 2001K003462ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045GEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
October 14, 1999K992769ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-GEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
July 9, 1997K972269DISPOSABLE PATIENT RETURN ELECTRODEGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov
March 11, 1996K960569DISPOSABLE PATIENT RETURN ELECTRODEGEISubstantially EquivalentErbe USA, Inc.accessdata.fda.gov

Compare with other makers

Updated June 9, 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.