FDA 510(k)

“POINT” Kinguide Robotic-Assisted Surgical System

K-번호: K220241 · 2022-08-09

결정일2022-08-09

제품 코드OLO

자문 위원회NE

결정Substantially Equivalent

기기 요약

“POINT” Kinguide Robotic-Assisted Surgical 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 2022-08-09 under 510(k) number K220241. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is Point Robotics MedTech, Inc.. The 510(k) number is K220241.

When did “POINT” Kinguide Robotic-Assisted Surgical System receive FDA 510(k) clearance?

“POINT” Kinguide Robotic-Assisted Surgical System received FDA 510(k) clearance on 2022-08-09, under 510(k) number K220241.

Who is the listed applicant for “POINT” Kinguide Robotic-Assisted Surgical 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 Robotic-Assisted Surgical System?

The FDA product code for “POINT” Kinguide Robotic-Assisted Surgical System is OLO.

Point Robotics MedTech, Inc.를 신청인으로 등재한 기타 기록

K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic System K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)K230087“POINT” Kinguide Agile Hybrid Navigation System

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