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FDA 510(k), K153049, LithoVue System
FDA 510(k), K153049, LithoVue System
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510(K) Number: K153049
Device Name: LithoVue System
Manufacturer: JEANNE O'TOOLE
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: FGB
Classification Product Code: KXA
Date Received: 10/20/2015
Decision Date: 11/13/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: LithoVue System
Manufacturer: JEANNE O'TOOLE
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: FGB
Classification Product Code: KXA
Date Received: 10/20/2015
Decision Date: 11/13/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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