Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614969

FEI Number

1000499348

Entity Name

BOWA-ELECTRONIC GMBH & CO. KG

City/State/Country

GOMARINGEN Baden-Wurttemberg, DE

Establishment Address

HEINRICH-HERTZ STRASSE 4-10, GOMARINGEN Baden-Wurttemberg D-72810, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BOWA-ELECTRONIC GMBH & CO. KG (Owner Number: 9031929)

Owner / Operator Contact Address

HEINRICH-HERTZ STRASSE 4-10, --, GOMARINGEN, DE-NOTA 72810, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HF-cable OLYMPUS BIPOLAR FORCEPS ARC 400 Novapulse KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD Electrosurgery cable Senhance Surgical System HF-resection electrodes RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION HF-RESECTION ELECTRODE ROLLERS AND NEEDLES LOOPS AND BANDS Stimuplex Pen HF cables HF-cable BIPOLAR GRASPING FORCEPS BIQ+ BOWA Neutral Electrodes HF-cable ROLLER ELECTRODE HF-cable UNIPOLAR OPTICAL BIOPSY FORCEPS HF-cables (reusable) KSEA BIPOLAR GOAGULATING FORCEPS Senhance Surgical System HF-cable and Adapter ENDOSCOPE AND ACCESSORIES HF-electrodes OLYMPUS OES LAPAROSCOPY SYSTEM HF-cable and Adapter HI-Q HAND INSTRUMENTS- UROLOGY

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	2016-09-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-04-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-05-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-05-12
SCV	Modular Electromechanical Surgical System	General, Plastic Surgery	Class 2	878.4964	2026-01-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-07-02
ISN	Cable	Physical Medicine	Class 1	890.3420	1997-10-17
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2016-09-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-22
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2012-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-06-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-03-14
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2016-09-22
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2016-09-22
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2016-09-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-01-26
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2025-08-06
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-07-02
GCP	Endoscope, Ac-Powered And Accessories	Gastroenterology, Urology	Class 2	876.1500	2016-09-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-09-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-09-22

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: EMERGO GLOBAL REPRESENTATION LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

BOWA-ELECTRONIC GMBH & CO. KG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3024712917	BOWA POLSKA Sp. z o o	Suchy Las, Zlotkowo Wielkopolskie, PL

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-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 9614969. Last updated year: 2026. Please use registration number 9614969 when referencing this establishment in official correspondence.