FDA.reportPublic FDA data

510(k) K252755

Device
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
Applicant
Point Robotics MedTech, Inc.
510(k) number
K252755
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-23
Date received
2025-08-29
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Wayne Kao
Address
7f, #219, Sec.3 Beixin Rd., Xindian Dist. New Taipei City TW 231 231

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OLO#

510(k), Device, Applicant table
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K254158SPINEART Navigation Instrument SystemSpineart SA2026-04-09
K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL2026-03-27
K260601REAL INTELLIGENCE™ CORI™Blue Belt Technologies, Inc.2026-03-26
K252037CUVIS-joint (CJ150)Curexo, Inc.2026-03-25
K253604TiLink-L Navigation InstrumentsSurGenTec, LLC2026-03-20
K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC2026-03-18
K260546Q Pedicle InstrumentsK2m, Inc.2026-03-17
K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.2026-03-03
K260222Mako Total Knee ApplicationMako Surgical Corp.2026-02-25
K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.2026-02-20
K254148VERTICALE GPS InstrumentsSilony Medical GmbH2026-02-19