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510(k) K230488

EL27-Compact; Sterile EHL-Probes by Walz Elektronik GmbH — Product Code FFK

K230488 is an FDA 510(k) premarket notification submitted by Walz Elektronik GmbH for the device "EL27-Compact; Sterile EHL-Probes". The FDA issued a decision of Substantially Equivalent on August 31, 2023. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2023
Date Received
February 23, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

Other clearances for product code FFK

  • K242888 — Electrohydraulic Lithotriptor (TCS-B3-II) (March 21, 2025)
  • K243032 — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (March 21, 2025)
  • K202813 — URO-TOUCH 9 French Probe (June 14, 2021)
  • K191124 — Swiss LithoClast Trilogy (May 29, 2019)
  • K162119 — UreTron PF Series Probe (August 29, 2016)
  • K160198 — UreTron MultiProbe Lithotripter System (February 23, 2016)
  • K132795 — CYBERWAND STERILE PROBE SET (November 26, 2013)
  • K130368 — AUTOLITH TOUCH; URO TOUCH (November 15, 2013)
  • K123038 — SWISS LITHOBREAKER (January 16, 2013)
  • K120303 — CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (June 5, 2012)

FDA data resources