POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
K-Number: K252755 · 2026-01-23
ApplicantPoint Robotics MedTech, Inc.
Decision Date2026-01-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System is a medical device manufactured by Point Robotics MedTech, Inc.. It received FDA 510(k) clearance on 2026-01-23 under approval number K252755. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the POINT Kinguide Agile Robotic Arm Surgical Stereotactic System?
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System is a medical device that received FDA 510(k) clearance on 2026-01-23. It is manufactured by Point Robotics MedTech, Inc.. The 510(k) number is K252755.
When was POINT Kinguide Agile Robotic Arm Surgical Stereotactic System approved by the FDA?
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System received FDA 510(k) clearance on 2026-01-23, under approval number K252755.
What company makes POINT Kinguide Agile Robotic Arm Surgical Stereotactic System?
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System is manufactured by Point Robotics MedTech, Inc..
What is the FDA product code for POINT Kinguide Agile Robotic Arm Surgical Stereotactic System?
The FDA product code for POINT Kinguide Agile Robotic Arm Surgical Stereotactic System is OLO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.