Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610614

FEI Number

3002806920

Entity Name

ERBE ELEKTROMEDIZIN GMBH

City/State/Country

TUEBINGEN Baden-Wurttemberg, DE

Establishment Address

WALDHOERNLESTRASSE 17, TUEBINGEN Baden-Wurttemberg 72072, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ERBE ELEKTROMEDIZIN GMBH (Owner Number: 8010173)

Owner / Operator Contact Address

WALDHOERNLESTRASSE 17, --, TUEBINGEN, DE-NOTA 72072, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101108

PMA Number

N/A

All Registered Proprietary Names

NESSY/Single Return Electrodes ERBE VIO 300 D with Accessories APC Applicators ERBEFLO 2 Disposable Tubing System VIO® 3 with Accessories Return Electrode Connecting Cables ERBE EIP 2 FiAPC plus probes ERBEJET® 2 System APC 2 and Accessories HybridTherm System: Electrosurgical Unit VIO 3, Cryosurgical Unit ERBECRYO 2, HybridTherm probes, accessories ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe NESSY Omega Return Electrodes FiAPC Plus APCapplicators APC 3 Argon Plasma Coagulation Unit VIO® Cart HybridAPC probe APC Pressure Reducer w/Sensor FiAPC® probes MOVIVA Hybrid Ablation Probe ERBEJET 2 System ERBEJET 2 two pedal footswitch ERBE ESU Model VIO dV with accessories VIO 200 S ERBE VIO ESU APC Integrated Filter Probes FiAPC probe w/filter 2200A, O.D. 3.6mm/10.8Fr, L. 2.2m/7.2ft Erbe APCapplicators ERBE Hybrid Knife HybridAPC probe HybridAPC Probe ERBEJET® 2 System ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe Accessories for ERBE ESUs ERBE VIO 100 C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-03-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2011-09-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-05-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2007-12-06
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2005-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-03-25
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2023-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2024-08-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-22
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-08-22
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2026-04-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-11-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-01-07
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-01-07
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-05-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-09-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-04-05
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-03-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-09-06
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-07-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-07-18
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2015-10-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-10-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-09-16

Official Correspondent

No official correspondent registered.

US Agent Details

JOHN TARTAL Business: ERBE USA, INC. Email: John.Tartal@erbe-usa.com Phone: (770) 9554400

Related Public Records

Same Entity

ERBE ELEKTROMEDIZIN GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009762450	ERBE Elektromedizin GmbH	Rangendingen Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0037-05	N/A	2	NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610614. Last updated year: 2026. Please use registration number 9610614 when referencing this establishment in official correspondence.