POINT Kinguide Robotic-Assisted Surgical System
K-Number: K220241 · 2022-08-09
ApplicantPoint Robotics MedTech, Inc.
Decision Date2022-08-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
POINT Kinguide Robotic-Assisted Surgical System is a medical device manufactured by Point Robotics MedTech, Inc.. It received FDA 510(k) clearance on 2022-08-09 under approval number K220241. 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 Robotic-Assisted Surgical System?
POINT Kinguide Robotic-Assisted Surgical System is a medical device that received FDA 510(k) clearance on 2022-08-09. It is manufactured by Point Robotics MedTech, Inc.. The 510(k) number is K220241.
When was POINT Kinguide Robotic-Assisted Surgical System approved by the FDA?
POINT Kinguide Robotic-Assisted Surgical System received FDA 510(k) clearance on 2022-08-09, under approval number K220241.
What company makes POINT Kinguide Robotic-Assisted Surgical System?
POINT Kinguide Robotic-Assisted Surgical System is manufactured by Point Robotics MedTech, Inc..
What is the FDA product code for POINT Kinguide Robotic-Assisted Surgical System?
The FDA product code for POINT Kinguide Robotic-Assisted Surgical 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.