Data / Medical devices / United States / Monteris Medical Corp

Monteris Medical Corp: FDA-registered device maker in Minnetonka, MN, United States, 20 510(k) clearances

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

Monteris Medical Corp is registered with the FDA (registration 3009970070) in Minnetonka, MN, United States. It lists 7 device types. The FDA files 20 510(k) clearances under its listings, the newest dated June 4, 2024. 3 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Monteris Medical Corp

FDA registration number: 3009970070
Address: 131 Cheshire Lane, Suite 100, Minnetonka, MN, United States, 55305
Owner or operator: Monteris Medical Corp (10042500)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 3, 2012
Registered through: 2026
Brand names listed: AtamA System, AutoLITT; NeuroBlate System, Fusion, Fusion-S, Fusion-S Software, M Vision, M Vision Software, M-Vision and more

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Neurosurgical Laser With Mr Thermography	ONO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, X-Ray, Film Marking, Radiographic	JAC	1	Complaint file establishment, 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
June 4, 2024	K240877	Monteris Medical NeuroBlate System	ONO	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
December 8, 2023	K231061	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
March 15, 2023	K222983	NeuroBlate Fusion-S Software V3.17	GEX	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
August 21, 2020	K201056	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical, Inc.	accessdata.fda.gov
January 3, 2020	K193375	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
October 15, 2018	K182036	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
November 17, 2017	K173305	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
October 20, 2017	K172881	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
July 25, 2017	K171255	Monteris Medical NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical, Inc.	accessdata.fda.gov
April 7, 2017	K170724	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
October 26, 2016	K162762	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical, Inc.	accessdata.fda.gov
February 19, 2015	K143457	NeuroBlate System	GEX	Substantially Equivalent	Monteris Medical, Inc.	accessdata.fda.gov
August 11, 2014	K141983	NEUROBLATE SYSTEM	GEX	Substantially Equivalent	Monteris Medical Corp.	accessdata.fda.gov
January 27, 2014	K132444	ATAMA SYSTEM	MOS	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
July 30, 2013	K131955	NEUROBLATE(TM) SYSTEM	GEX	Substantially Equivalent	Monteris Medical, Inc.	accessdata.fda.gov
July 11, 2013	K131278	MONTERIS MEDICAL NEUROBLATE SYSTEM	GEX	Substantially Equivalent	Monteris Medical, Inc.	accessdata.fda.gov
April 1, 2013	K120561	NEUROBLATE SYSTEM	GEX	Substantially Equivalent	Monteris Medical, Inc.	accessdata.fda.gov
April 8, 2011	K110411	ATAMA SYSTEM	MOS	Substantially Equivalent	Monteris Medical, Inc.	accessdata.fda.gov
May 1, 2009	K081509	MONTERIS MEDICAL AUTOLITT LASER PROBE	GEX	Substantially Equivalent	Monteris Medical,	accessdata.fda.gov
April 3, 2003	K030172	SMALL HIGH SPEED MOTOR DRILL SYSTEM	HBE	Substantially Equivalent	Brasseler USA I, L.P.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 5, 2017	78315	Class I	Terminated	MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.	The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.	accessdata.fda.gov
March 25, 2016	73849	Class I	Terminated	NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser P	Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.	accessdata.fda.gov
October 3, 2014	69514	Class II	Terminated	SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that	Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.	accessdata.fda.gov

Compare with other makers

Updated June 4, 2024. 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.