Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PATHASSIST LIGHT SEEKER

K-Number: K113522 · 2012-01-27

ApplicantEntellus Medical, Inc.
Decision Date2012-01-27
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PATHASSIST LIGHT SEEKER is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc.. It received FDA 510(k) clearance on 2012-01-27 under 510(k) number K113522. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHASSIST LIGHT SEEKER?

PATHASSIST LIGHT SEEKER is a medical device that received FDA 510(k) clearance on 2012-01-27. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K113522.

When did PATHASSIST LIGHT SEEKER receive FDA 510(k) clearance?

PATHASSIST LIGHT SEEKER received FDA 510(k) clearance on 2012-01-27, under 510(k) number K113522.

Who is the listed applicant for PATHASSIST LIGHT SEEKER?

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

What is the FDA product code for PATHASSIST LIGHT SEEKER?

The FDA product code for PATHASSIST LIGHT SEEKER is LRC.

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 Entellus Medical, 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.

K220027Audion ET dilation systemK163435Entellus Medical Reinforced Anesthesia NeedleK163509XprESS ENT Dilation SystemK133563PATHASSIST LIGHT SEEKERK132440XPRESS MULTI-SINUS DILATION TOOLK130503PATHASSIST LED LIGHT FIBER

View all 23 devices →

Related Devices (Code: LRC)

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.

K230258BB 8 Sinus Dilation KitExcelent, Inc.K212774VenSure LightGuideIntersect Ent.K201398SINUSPRIME Dilation SystemStryker EntK201115Next Generation Balloon Dilation SystemAcclarent, Inc.K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLC

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.

↑