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Stockert GMBH: FDA-registered device maker in FREIBURG Baden-Wurttemberg, Germany, 2 510(k) clearances and 4 PMA approvals

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

Stockert GMBH is registered with the FDA (registration 3015537323) in FREIBURG Baden-Wurttemberg, Germany. It lists 5 device types. The FDA files 2 510(k) clearances and 4 PMA approvals under its listings, the newest dated February 24, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015537323
Address: Boetzinger Strasse 31, FREIBURG Baden-Wurttemberg, Germany, 79111
Owner or operator: Stockert GmbH (9042012)
Roles: Manufacturer
First device listed: January 18, 2001
Registered through: 2026
Brand names listed: INTELLAGEN Catheter Adapter Cable, 0.3 Meter, INTELLAGEN ECG Connection Cable, 3 Meter, INTELLAGEN Foot Pedal, INTELLAGEN Foot Pedal Extension Cable, 7 Meter, INTELLAGEN Grounding Cable, 3 Meter, INTELLAGEN Irrigation Pump, INTELLAGEN Irrigation Pump Connection Cable, 1 Meter, INTELLAGEN Irrigation Pump Connection Cable, 10 Meter and more

Devices it lists

Device	Product code	Class	Role	Source
Cardiac Ablation Percutaneous Catheter	LPB	3	Manufacturer	accessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	3	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Battery-Powered	BXN	2	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
March 22, 2007	K070134	MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098	BXN	Substantially Equivalent	Stockert GmbH	accessdata.fda.gov
November 17, 2005	K052313	STIMUPLEX HNS-12, MODEL 4892098	BXN	Substantially Equivalent	Stockert GmbH	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 24, 2016	P150005	BLAZER OPEN-IRRIGATED ABLATION CATHETER	OAD	91	December 5, 2025	accessdata.fda.gov
August 25, 2003	P020025	EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM	OAD	141	October 17, 2025	accessdata.fda.gov
May 31, 2000	P990071	STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR	LPB	65	December 23, 2025	accessdata.fda.gov
October 28, 1994	P920047	EPT-1000 CARDIAC ABLATION SYSTEM	LPB	133	October 17, 2025	accessdata.fda.gov

Compare with other makers

Updated December 5, 2025. 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.