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Seisa Medical Inc: FDA-registered device maker in El Paso, TX, United States, 13 510(k) clearances and 1 PMA approval

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

Seisa Medical Inc is registered with the FDA (registration 3006131984) in El Paso, TX, United States. It lists 17 device types. The FDA files 13 510(k) clearances and 1 PMA approval under its listings, the newest dated August 2, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006131984
Address: 9005 Montana Ave, El Paso, TX, United States, 79925
Owner or operator: SEISA MEDICAL -TEKNI PLEX (10023408)
Roles: Complaint file establishment
First device listed: December 19, 2014
Registered through: 2026
Brand names listed: AMEDA INC, Bard Peripheral Vascular, Inc., Burpee Medsystems, LLC, COOK INC., COOK MEDICAL INC, DermaClip® US, LLC, HOLLISTER INC, OLYMPUS GYRUS and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Diagnostic	DQO	2	Complaint file establishment	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Complaint file establishment	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment	accessdata.fda.gov
Collector, Ostomy	EXB	1	Complaint file establishment	accessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)	HHK	2	Complaint file establishment	accessdata.fda.gov
Enema Kit	FCE	1	Complaint file establishment	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Complaint file establishment	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Complaint file establishment	accessdata.fda.gov
Introducer, Catheter	DYB	2	Complaint file establishment	accessdata.fda.gov
Protector, Ostomy	EXE	1	Complaint file establishment	accessdata.fda.gov
Pump, Breast, Non-Powered	HGY	1	Complaint file establishment	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Complaint file establishment	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Complaint file establishment	accessdata.fda.gov
System, Abortion, Vacuum	HHI	2	Complaint file establishment	accessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm Treatment	MIH	3	Complaint file establishment	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Complaint file establishment	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Complaint file establishment	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
August 2, 2013	K131493	SIDEKICK AND USHER SUPPORT CATHETERS	DQY	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
February 14, 2013	K123235	EQUAFLOW MULTIVALVE INFUSION CATHETER	DYB	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
November 22, 2010	K102519	FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX	FGE	Unknown	Flexible Stenting Solutions, Inc.	accessdata.fda.gov
February 4, 2009	K083153	ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007	KNT	Unknown	Hollister, Inc.	accessdata.fda.gov
June 23, 2003	K030935	BERKELEY V-10 VACUUM CURETTAGE SYSTEM	HHI	Substantially Equivalent	Acmi Corporation	accessdata.fda.gov
January 8, 2002	K011876	DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2	HIG	Substantially Equivalent	Circon Video	accessdata.fda.gov
August 15, 2001	K011519	AMEDA HYGIENIKIT	HGY	Substantially Equivalent	Hollister, Inc.	accessdata.fda.gov
August 18, 1995	K953232	HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE	KNT	Substantially Equivalent	Hollister, Inc.	accessdata.fda.gov
April 19, 1995	K941743	CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP	HIG	Substantially Equivalent	Cabot Medical Corp.	accessdata.fda.gov
March 5, 1990	K896917	HYSTEROSCOPE	HIH	Substantially Equivalent	Cabot Medical Corp.	accessdata.fda.gov
February 26, 1990	K895044	DUAL GUIDE INTRODUCER CATHETER	DYB	Substantially Equivalent	Cook, Inc.	accessdata.fda.gov
October 17, 1989	K893888	HOLLISTER FEEDING TUBE ATTACHMENT DEVICE	KNT	Substantially Equivalent	Hollister, Inc.	accessdata.fda.gov
July 28, 1988	K882796	SLIP-COAT(TM) CATHETERS	DQO	Substantially Equivalent	Cook, Inc.	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
May 23, 2003	P020018	ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM	MIH	65	September 17, 2026	accessdata.fda.gov

Compare with other makers

Updated September 17, 2026. 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.