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FDA 510(k)

CYBERWAND STERILE PROBE SET

K-Number: K132795 · 2013-11-26

ApplicantCybersonics, Inc.
Decision Date2013-11-26
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYBERWAND STERILE PROBE SET is the device name listed in this FDA 510(k) record. The listed applicant is Cybersonics, Inc.. It received FDA 510(k) clearance on 2013-11-26 under 510(k) number K132795. 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 STERILE PROBE SET?

CYBERWAND STERILE PROBE SET is a medical device that received FDA 510(k) clearance on 2013-11-26. The listed applicant is Cybersonics, Inc.. The 510(k) number is K132795.

When did CYBERWAND STERILE PROBE SET receive FDA 510(k) clearance?

CYBERWAND STERILE PROBE SET received FDA 510(k) clearance on 2013-11-26, under 510(k) number K132795.

Who is the listed applicant for CYBERWAND STERILE PROBE SET?

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 STERILE PROBE SET?

The FDA product code for CYBERWAND STERILE PROBE SET 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 SystemK120303CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEMK102169CYBERWAND LITHOTRIPTERK072422CYBERWAND 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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