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FDA 510(k)

VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR

K-Number: K092033 · 2010-04-30

ApplicantElmed USA
Decision Date2010-04-30
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Elmed USA. It received FDA 510(k) clearance on 2010-04-30 under 510(k) number K092033. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR?

VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Elmed USA. The 510(k) number is K092033.

When did VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR receive FDA 510(k) clearance?

VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR received FDA 510(k) clearance on 2010-04-30, under 510(k) number K092033.

Who is the listed applicant for VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR?

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

What is the FDA product code for VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR?

The FDA product code for VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR is FFK.

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Related Devices (Code: FFK)

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.

K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbHK202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.

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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