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FDA 510(k)

CYBERWAND STERILE PADS, MODEL: CW-RBPBX

K-Number: K072422 · 2007-10-24

ApplicantCybersonics, Inc.
Decision Date2007-10-24
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYBERWAND STERILE PADS, MODEL: CW-RBPBX is the device name listed in this FDA 510(k) record. The listed applicant is Cybersonics, Inc.. It received FDA 510(k) clearance on 2007-10-24 under 510(k) number K072422. 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 PADS, MODEL: CW-RBPBX?

CYBERWAND STERILE PADS, MODEL: CW-RBPBX is a medical device that received FDA 510(k) clearance on 2007-10-24. The listed applicant is Cybersonics, Inc.. The 510(k) number is K072422.

When did CYBERWAND STERILE PADS, MODEL: CW-RBPBX receive FDA 510(k) clearance?

CYBERWAND STERILE PADS, MODEL: CW-RBPBX received FDA 510(k) clearance on 2007-10-24, under 510(k) number K072422.

Who is the listed applicant for CYBERWAND STERILE PADS, MODEL: CW-RBPBX?

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 PADS, MODEL: CW-RBPBX?

The FDA product code for CYBERWAND STERILE PADS, MODEL: CW-RBPBX 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 SYSTEMK102169CYBERWAND LITHOTRIPTERK052135CYBERSONICS 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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