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FDA 510(k)

LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM

K-Number: K093494 · 2010-03-30

ApplicantPathfinder Therapeutics, Inc.
Decision Date2010-03-30
Product CodeOEW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pathfinder Therapeutics, Inc.. It received FDA 510(k) clearance on 2010-03-30 under 510(k) number K093494. The device is classified under product code OEW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM?

LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-30. The listed applicant is Pathfinder Therapeutics, Inc.. The 510(k) number is K093494.

When did LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM receive FDA 510(k) clearance?

LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM received FDA 510(k) clearance on 2010-03-30, under 510(k) number K093494.

Who is the listed applicant for LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM?

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

What is the FDA product code for LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM?

The FDA product code for LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM is OEW.

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 Pathfinder Therapeutics, 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.

K101979EXPLORER LIVER (PASSIVE TRACKING)K082228PLANISIGHT LINASYSK071063LINASYS

Related Devices (Code: OEW)

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.

K101979EXPLORER LIVER (PASSIVE TRACKING)Pathfinder Therapeutics, Inc.K071063LINASYSPathfinder Therapeutics, Inc.

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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