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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Point Robotics MedTech, Inc.. It received FDA 510(k) clearance on 2026-01-23 under 510(k) 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. The listed applicant is Point Robotics MedTech, Inc.. The 510(k) number is K252755.

When did POINT Kinguide Agile Robotic Arm Surgical Stereotactic System receive FDA 510(k) clearance?

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System received FDA 510(k) clearance on 2026-01-23, under 510(k) number K252755.

Who is the listed applicant for POINT Kinguide Agile Robotic Arm Surgical Stereotactic System?

The FDA 510(k) record lists Point Robotics MedTech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Point Robotics MedTech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetK241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)K230087“POINT” Kinguide Agile Hybrid Navigation SystemK220241“POINT” Kinguide Robotic-Assisted Surgical System

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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.

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