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FDA 510(k)

ARTAS SYSTEM FROM RESTORATION ROBOTICS

K-Number: K123154 · 2013-02-19

ApplicantRestoration Robotics, Inc.
Decision Date2013-02-19
Product CodeONA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ARTAS SYSTEM FROM RESTORATION ROBOTICS is the device name listed in this FDA 510(k) record. The listed applicant is Restoration Robotics, Inc.. It received FDA 510(k) clearance on 2013-02-19 under 510(k) number K123154. The device is classified under product code ONA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTAS SYSTEM FROM RESTORATION ROBOTICS?

ARTAS SYSTEM FROM RESTORATION ROBOTICS is a medical device that received FDA 510(k) clearance on 2013-02-19. The listed applicant is Restoration Robotics, Inc.. The 510(k) number is K123154.

When did ARTAS SYSTEM FROM RESTORATION ROBOTICS receive FDA 510(k) clearance?

ARTAS SYSTEM FROM RESTORATION ROBOTICS received FDA 510(k) clearance on 2013-02-19, under 510(k) number K123154.

Who is the listed applicant for ARTAS SYSTEM FROM RESTORATION ROBOTICS?

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

What is the FDA product code for ARTAS SYSTEM FROM RESTORATION ROBOTICS?

The FDA product code for ARTAS SYSTEM FROM RESTORATION ROBOTICS is ONA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Restoration Robotics, 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.

K173358ARTAS SystemK123548THE ARTAS SYSTEMK103428THE ARTAS SYSTEM FROM RESTORATION ROBOTICS

Related Devices (Code: ONA)

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.

K173358ARTAS SystemRestoration Robotics, Inc.K123548THE ARTAS SYSTEMRestoration Robotics, Inc.K103428THE ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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