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FDA 510(k)

MICROVASIVE LITHOTRIPTOR FLEXPROBE II

K-Number: K002084 · 2000-07-19

ApplicantBoston Scientific Corp
Decision Date2000-07-19
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROVASIVE LITHOTRIPTOR FLEXPROBE II is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2000-07-19 under 510(k) number K002084. 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 MICROVASIVE LITHOTRIPTOR FLEXPROBE II?

MICROVASIVE LITHOTRIPTOR FLEXPROBE II is a medical device that received FDA 510(k) clearance on 2000-07-19. The listed applicant is Boston Scientific Corp. The 510(k) number is K002084.

When did MICROVASIVE LITHOTRIPTOR FLEXPROBE II receive FDA 510(k) clearance?

MICROVASIVE LITHOTRIPTOR FLEXPROBE II received FDA 510(k) clearance on 2000-07-19, under 510(k) number K002084.

Who is the listed applicant for MICROVASIVE LITHOTRIPTOR FLEXPROBE II?

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

What is the FDA product code for MICROVASIVE LITHOTRIPTOR FLEXPROBE II?

The FDA product code for MICROVASIVE LITHOTRIPTOR FLEXPROBE II 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

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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