UreTron PF Series Probe

FDA 510(k) K162119 · Med-Sonics Corp.

Substantially Equivalent

510(k) numberK162119

Submission

Device name
UreTron PF Series Probe
Applicant
Med-Sonics Corp.
Erie, PA, US
Received
August 1, 2016
Decision date
August 29, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FFK – Lithotriptor, Electro-Hydraulic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4480
Specialty
Gastroenterology, Urology

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K242888Electrohydraulic Lithotriptor (TCS-B3-II)FFK · Traditional Guangzhou Potent Medical Equipment Joint-Stock…03/21/2025SE
K230488EL27-Compact; Sterile EHL-ProbesFFK · Traditional Walz Elektronik GmbH08/31/2023SE
K202813URO-TOUCH 9 French ProbeFFK · Traditional Northgate Technologies, Inc.06/14/2021SE
K191124Swiss LithoClast TrilogyFFK · Special E.M.S Electro Medical Systems S.A05/29/2019SE
K160198UreTron MultiProbe Lithotripter SystemFFK · Special Med-Sonics Corp.02/23/2016SE
K132795Cyberwand Sterile Probe SetFFK · Special Cybersonics, Inc.11/26/2013SE
K130368Autolith Touch; Uro TouchFFK · Traditional Northgate Technologies, Inc.11/15/2013SE
K123038Swiss LithobreakerFFK · Traditional E.M.S Electro Medical Systems S.A01/16/2013SE
K120303Cyberwand Dual Action Ultrasonic Lithotripsy SystemFFK · Abbreviated Cybersonics, Inc.06/05/2012SE

More from Cybersonics, Inc.

510(k)DeviceDecision
K160198UreTron MultiProbe Lithotripter SystemFFK · Special 02/23/2016SE
K111058Uretron Model UrtFFK · Abbreviated 03/30/2012SE

Questions and answers

When was UreTron PF Series Probe cleared by the FDA?

UreTron PF Series Probe (K162119) received a 510(k) decision of Substantially Equivalent on August 29, 2016, 28 days after the submission was received.

What is the product code of K162119?

The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.