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FDA 510(k)

LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER

K-Number: K974796 · 1998-03-12

ApplicantMedispec, Ltd.
Decision Date1998-03-12
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER is the device name listed in this FDA 510(k) record. The listed applicant is Medispec, Ltd.. It received FDA 510(k) clearance on 1998-03-12 under 510(k) number K974796. 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 LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER?

LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER is a medical device that received FDA 510(k) clearance on 1998-03-12. The listed applicant is Medispec, Ltd.. The 510(k) number is K974796.

When did LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER receive FDA 510(k) clearance?

LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER received FDA 510(k) clearance on 1998-03-12, under 510(k) number K974796.

Who is the listed applicant for LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER?

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

What is the FDA product code for LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER?

The FDA product code for LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER is FFK.

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.

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Other records listing Medispec, Ltd. 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.

K210166Omnispec ED1000K063504ECONOLITH EM1000K040461ECONOLITH E3000, MODEL 3000 (SW-6)

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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