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FDA 510(k)

SPYGLASS IRRIGATION SYSTEM

K-Number: K063700 · 2007-02-08

ApplicantMedical Scientific, Inc.
Decision Date2007-02-08
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPYGLASS IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Scientific, Inc.. It received FDA 510(k) clearance on 2007-02-08 under 510(k) number K063700. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPYGLASS IRRIGATION SYSTEM?

SPYGLASS IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-08. The listed applicant is Medical Scientific, Inc.. The 510(k) number is K063700.

When did SPYGLASS IRRIGATION SYSTEM receive FDA 510(k) clearance?

SPYGLASS IRRIGATION SYSTEM received FDA 510(k) clearance on 2007-02-08, under 510(k) number K063700.

Who is the listed applicant for SPYGLASS IRRIGATION SYSTEM?

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

What is the FDA product code for SPYGLASS IRRIGATION SYSTEM?

The FDA product code for SPYGLASS IRRIGATION SYSTEM is LJH.

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 Medical Scientific, 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.

K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMK031564CSSK011202MSI BIPOLAR SHEATHK981387EVANESCE SCAR MANAGEMENT SYSTEM

Related Devices (Code: LJH)

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.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLCK042457URO PROW.O.M. World of Medicine AG

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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