Data / Medical devices / Germany / Bowa-Electronic GMBH

Bowa-Electronic GMBH: FDA-registered device maker in GOMARINGEN Baden-Wurttemberg, Germany, 2 510(k) clearances

Name: Bowa-Electronic GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bowa-Electronic GMBH is registered with the FDA (registration 9614969) in GOMARINGEN Baden-Wurttemberg, Germany. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9614969
FEI number: 1000499348
Address: Heinrich-Hertz STR. 4-10, GOMARINGEN Baden-Wurttemberg, Germany, D-72810
Owner or operator: BOWA-ELECTRONIC GMBH & CO. KG (9031929)
Roles: Contract manufacturer, Manufacturer
First device listed: October 17, 1997
Registered through: 2026
Brand names listed: ARC 400, Autocon III 400, BIPOLAR GRASPING FORCEPS BIQ+, BOWA Neutral Electrodes, ENDOSCOPE AND ACCESSORIES, ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD, Electrosurgery cable, Endovapor®2 and more

Devices it lists

Device	Product code	Class	Role	Source
Cable	ISN	1	Contract manufacturer	accessdata.fda.gov
Electrode, Electrosurgical, Active, Urological	FAS	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscope, Ac-Powered And Accessories	GCP	2	Contract manufacturer	accessdata.fda.gov
Forceps, Biopsy, Electric	KGE	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Contract manufacturer	accessdata.fda.gov
Modular Electromechanical Surgical System	SCV	2	Contract manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Contract manufacturer	accessdata.fda.gov
Resectoscope	FJL	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve, Battery-Powered	BXN	2	Contract manufacturer	accessdata.fda.gov
System, Surgical, Computer Controlled Instrument	NAY	2	Contract 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 2, 2020	K193591	ARC 400	GEI	Substantially Equivalent	Bowa-Electronics GmbH & Co. KG	accessdata.fda.gov
February 15, 2018	K173877	BOWA Neutral Electrodes	GEI	Substantially Equivalent	Bowa-Electronics GmbH & Co. KG	accessdata.fda.gov

Compare with other makers

Updated April 2, 2020. 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.