Data / Medical devices / United States / Sirtex Medical Inc.

Sirtex Medical Inc.: FDA-registered device maker in Woburn, MA, United States, 1 510(k) clearance and 2 PMA approvals

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

Sirtex Medical Inc. is registered with the FDA (registration 3012690638) in Woburn, MA, United States. It lists 7 device types. The FDA files 1 510(k) clearance and 2 PMA approvals under its listings, the newest dated April 4, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012690638
Address: 300 Unicorn Park Dr., 2nd Fl., Woburn, MA, United States, 01801
Owner or operator: Sirtex Medical Inc. (9047689)
Roles: Complaint file establishment, Specification developer
First device listed: December 19, 2003
Registered through: 2026
Brand names listed: LAVA Liquid Embolic System (LES), LAVA Liquid Embolic System (LES) Kit, LAVA Liquid Embolic System (Lava LES) and LAVA Mixing Kit, LAVA Mixing Kit, SIR-Spheres, SIR-Spheres Accessories Pack, SIR-Spheres Delivery Box, SIR-Spheres Delivery Set and more

Devices it lists

Device	Product code	Class	Role	Source
Embolization Agent, Vascular	QVG	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Holder, Syringe, Lead	IWR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Microspheres Radionuclide	NAW	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Shield, Vial	IWW	1	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Applicator, Radionuclide, Manual	IWJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Complaint file establishment, Specification developer	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
October 23, 2020	K202392	SIR-Spheres Microspheres Activity Calculator (SMAC)	KPS	Substantially Equivalent	Sirtex Medical US Holdings, 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
April 4, 2023	P220020	Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit	QVG	8	July 9, 2026	accessdata.fda.gov
March 5, 2002	P990065	SIR-SPHERES	NAW	14	May 7, 2026	accessdata.fda.gov

Compare with other makers

Updated July 9, 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.