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FDA 510(k)

CYBERWAND LITHOTRIPTER

K-Number: K102169 · 2010-08-30

ApplicantCybersonics, Inc.
Decision Date2010-08-30
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYBERWAND LITHOTRIPTER is the device name listed in this FDA 510(k) record. The listed applicant is Cybersonics, Inc.. It received FDA 510(k) clearance on 2010-08-30 under 510(k) number K102169. 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 CYBERWAND LITHOTRIPTER?

CYBERWAND LITHOTRIPTER is a medical device that received FDA 510(k) clearance on 2010-08-30. The listed applicant is Cybersonics, Inc.. The 510(k) number is K102169.

When did CYBERWAND LITHOTRIPTER receive FDA 510(k) clearance?

CYBERWAND LITHOTRIPTER received FDA 510(k) clearance on 2010-08-30, under 510(k) number K102169.

Who is the listed applicant for CYBERWAND LITHOTRIPTER?

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

What is the FDA product code for CYBERWAND LITHOTRIPTER?

The FDA product code for CYBERWAND LITHOTRIPTER is FFK.

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Other records listing Cybersonics, 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.

K171024ShockPulse-SE Lithotripsy SystemK132795CYBERWAND STERILE PROBE SETK120303CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEMK072422CYBERWAND STERILE PADS, MODEL: CW-RBPBXK052135CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER

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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