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FDA 510(k)

VISCOUS FLUID SYSTEM

K-Number: K963434 · 1996-11-25

ApplicantEscalon Trek Medical
Decision Date1996-11-25
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VISCOUS FLUID SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Escalon Trek Medical. It received FDA 510(k) clearance on 1996-11-25 under 510(k) number K963434. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISCOUS FLUID SYSTEM?

VISCOUS FLUID SYSTEM is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Escalon Trek Medical. The 510(k) number is K963434.

When did VISCOUS FLUID SYSTEM receive FDA 510(k) clearance?

VISCOUS FLUID SYSTEM received FDA 510(k) clearance on 1996-11-25, under 510(k) number K963434.

Who is the listed applicant for VISCOUS FLUID SYSTEM?

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

What is the FDA product code for VISCOUS FLUID SYSTEM?

The FDA product code for VISCOUS FLUID SYSTEM is MRH.

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 Escalon Trek Medical 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.

K963417VITLITE (TR7700)K924999AUTOPOLE REGULATOR SYSTEM

Related Devices (Code: MRH)

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.

K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc.K243503VIA360™ Surgical SystemNew World Medical, Inc.K232214OMNI Surgical SystemSight Sciences, Inc.K213173TrabEx ProMicrosurgical Technologies, Inc.K212797iPrime Viscodelivery SystemGlaukosK211680Streamline Surgical SystemNew World Medical, 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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