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510(k) K130368

AUTOLITH TOUCH; URO TOUCH by Northgate Technologies, Inc. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2013
Date Received
February 14, 2013
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

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  • K041560 — FLO-ASSISTANT (September 28, 2004)
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  • K022052 — 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 (January 24, 2003)
  • K010053 — HUMI-FLOW, MODEL 6-850-00/ 01/02 (October 23, 2001)
  • K011928 — HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 (August 10, 2001)
  • K001325 — FLO ASSISTANT, MODEL 4-250-00 (August 18, 2000)
  • K993778 — HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 (January 6, 2000)

Other clearances for product code FFK

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  • K242888 — Electrohydraulic Lithotriptor (TCS-B3-II) (March 21, 2025)
  • K230488 — EL27-Compact; Sterile EHL-Probes (August 31, 2023)
  • 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)
  • K123038 — SWISS LITHOBREAKER (January 16, 2013)
  • K120303 — CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (June 5, 2012)