Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010456

FEI Number

3002477156

Entity Name

GUENTER BISSINGER MEDIZINTECHNIK GMBH

City/State/Country

TENINGEN Baden-Wurttemberg, DE

Establishment Address

Hans-Theisen-Str. 1, TENINGEN Baden-Wurttemberg 79331, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GUENTER BISSINGER MEDIZINTECHNIK GMBH (Owner Number: 8010456)

Owner / Operator Contact Address

Hans-Theisen-Str. 1, TENINGEN, DE-BW D-79331, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2009-11-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-02-24
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2021-07-26
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-10-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-04-13
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-11-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-11-13
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-10-12
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-10-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-10-12
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1986-04-06
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-10-12
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-10-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-05-22
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1986-05-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-10
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-12-17
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1979-09-10
HWA	Impactor	Orthopedic	Class 1	888.4540	2017-06-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-08-29

Official Correspondent

MATTHIAS BISSINGER

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

GUENTER BISSINGER MEDIZINTECHNIK GMBH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K950499	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS	1995-06-16
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

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-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010456. Last updated year: 2026. Please use registration number 8010456 when referencing this establishment in official correspondence.