510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Monteris Medical Corp

Minnetonka, MN, US

MONTERIS MEDICAL CORP appears in FDA device records in Minnetonka, MN. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
4
Registered establishments
1

510(k) clearance history

FDA records hold 21 510(k) clearances for Monteris Medical Corp between 2009 and 2026. The busiest year on record is 2017, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Monteris Medical Corp, by decision year
YearClearances
20092
20111
20133
20142
20151
20161
20174
20181
20202
20232
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260976NeuroBlate SystemONOSubstantially Equivalent
K240877Monteris Medical NeuroBlate SystemONOSubstantially Equivalent
K231061NeuroBlate SystemGEXSubstantially Equivalent
K222983NeuroBlate Fusion-S Software V3.17GEXSubstantially Equivalent
K201056NeuroBlate SystemGEXSubstantially Equivalent
K193375NeuroBlate SystemGEXSubstantially Equivalent
K182036NeuroBlate SystemGEXSubstantially Equivalent
K173305NeuroBlate SystemGEXSubstantially Equivalent
K172881NeuroBlate SystemGEXSubstantially Equivalent
K171255Monteris Medical NeuroBlate SystemGEXSubstantially Equivalent
K170724NeuroBlate SystemGEXSubstantially Equivalent
K162762NeuroBlate SystemGEXSubstantially Equivalent
K143457NeuroBlate SystemGEXSubstantially Equivalent
K141983NEUROBLATE SYSTEMGEXSubstantially Equivalent
K132444ATAMA SYSTEMMOSSubstantially Equivalent
K131955NEUROBLATE(TM) SYSTEMGEXSubstantially Equivalent
K131278MONTERIS MEDICAL NEUROBLATE SYSTEMGEXSubstantially Equivalent
K120561NEUROBLATE SYSTEMGEXSubstantially Equivalent
K110411ATAMA SYSTEMMOSSubstantially Equivalent
K090240MONTERIS MEDICAL UFOHAWSubstantially Equivalent
K081509MONTERIS MEDICAL AUTOLITT LASER PROBEGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Monteris Medical Corp, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30099700703009970070MONTERIS MEDICAL CORP131 Cheshire Lane, Suite 100, Minnetonka, MN 55305 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0194-2018MONTERIS 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.Class ITerminated
Z-1614-2016NeuroBlate 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 Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.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.Class ITerminated
Z-0228-2015FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.Class IITerminated
Z-0227-2015SideFire 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 create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain