Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM

K-Number: K120303 · 2012-06-05

ApplicantCybersonics, Inc.
Decision Date2012-06-05
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cybersonics, Inc.. It received FDA 510(k) clearance on 2012-06-05 under 510(k) number K120303. 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 DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM?

CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-05. The listed applicant is Cybersonics, Inc.. The 510(k) number is K120303.

When did CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM receive FDA 510(k) clearance?

CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM received FDA 510(k) clearance on 2012-06-05, under 510(k) number K120303.

Who is the listed applicant for CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM?

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 DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM?

The FDA product code for CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SETK102169CYBERWAND 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑