# Monteris Medical,

- Location (FDA's records): Plymouth, MN
- FDA decisions: 22 (2009–2026): 22 510(k) clearances
- Names in FDA's records: Monteris Medical, (11); Monteris Medical, Inc. (8); Monteris Medical (2); Monteris Medical Corp. (1)
- Product codes: GEX (16), ONO (3), MOS (2), HAW (1)
- 510(k) review time since 2016: median 44 days, against 90 for FDA's reviews in the same codes and years (8 of 12 faster)
- Predicates its devices cite: 61 (51 its own); citations of its devices by later devices: 55 (51 its own)
- Recalls linked to its devices: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Image-Guided Neurologics, Inc.: 2 (https://510kreport.com/company/image-guided-neurologics)
- Biotex, Inc.: 1 (https://510kreport.com/company/biotex)
- Laserscope: 1 (https://510kreport.com/company/laserscope)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- Imris, Inc.: 1 (https://510kreport.com/company/imris)
- Clinical Laserthermia Systems, AB: 1 (https://510kreport.com/company/clinical-laserthermia-systems)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)

## Firms that cite its devices most
- Medtronic Navigation, Inc.: 2 (https://510kreport.com/company/medtronic-navigation)
- Voyager Therapeutics, Inc.: 1 (https://510kreport.com/company/voyager-therapeutics)
- Clinical Laserthermia Systems, AB: 1 (https://510kreport.com/company/clinical-laserthermia-systems)

## Its most-cited devices
- K120561: Neuroblate System (2013), cited by 7
- K141983: Neuroblate System (2014), cited by 5
- K162762: NeuroBlate System (2016), cited by 4
- K240877: Monteris Medical NeuroBlate System (2024), cited by 4
- K143457: NeuroBlate System (2015), cited by 4
- K081509: Monteris Medical Autolitt Laser Probe (2009), cited by 3

## Recent decisions
- K262315: NeuroBlate System (Sep 3, 2026)
- K260976: NeuroBlate System (Apr 23, 2026)
- K240877: Monteris Medical NeuroBlate System (Jun 4, 2024)
- K231061: NeuroBlate System (Dec 8, 2023)
- K222983: NeuroBlate Fusion-S Software V3.17 (Mar 15, 2023)
- K201056: NeuroBlate System (Aug 21, 2020)
- K193375: NeuroBlate System (Jan 3, 2020)
- K182036: NeuroBlate System (Oct 15, 2018)

Source page: https://510kreport.com/company/monteris-medical