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FDA 510(k)

PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000

K-Number: K032958 · 2004-02-17

ApplicantUnited Medical Systems, Inc.
Decision Date2004-02-17
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 is the device name listed in this FDA 510(k) record. The listed applicant is United Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-02-17 under 510(k) number K032958. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000?

PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 is a medical device that received FDA 510(k) clearance on 2004-02-17. The listed applicant is United Medical Systems, Inc.. The 510(k) number is K032958.

When did PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 receive FDA 510(k) clearance?

PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 received FDA 510(k) clearance on 2004-02-17, under 510(k) number K032958.

Who is the listed applicant for PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000?

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

What is the FDA product code for PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000?

The FDA product code for PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 is LNS.

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 United Medical Systems, 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.

K072538PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTERK894949SQAK893003TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASEK863645SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000

Related Devices (Code: LNS)

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.

K261086Break WaveSonomotion, Inc.K252913Break WaveSonomotion, Inc.K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.K221903Delta III ProDornier Medtech America, Inc.K213772LM-9300 Plus LithotripterLite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy America

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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