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510(k) K850298

ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM by Cabot Medical Corp. — Product Code FEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
January 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Ultrasonic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

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  • K951714 — CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER (July 11, 1995)
  • K941743 — CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP (April 19, 1995)
  • K934115 — 3000 ELECTRONIC INSUFFLATOR MODIFICATION (March 15, 1995)
  • K932293 — CABOT MEDICAL BIPOLAR CUTTING FORCEPS (July 27, 1994)
  • K930954 — THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV (June 30, 1994)
  • K932626 — CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB (June 8, 1994)
  • K935786 — CORSON AND NEZHAT SUCTION/IRRIGATION PROBES (May 19, 1994)

Other clearances for product code FEO

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  • K182490 — Swiss LithoClast Trilogy (October 9, 2018)
  • K181997 — Swiss LithoClast Trilogy (August 30, 2018)
  • K181364 — Swiss LithoClast Trilogy (June 20, 2018)
  • K173234 — Swiss LithoClast Trilogy (January 10, 2018)
  • K171024 — ShockPulse-SE Lithotripsy System (August 21, 2017)
  • K142428 — Shock Pulse-SE Lithotripsy System CYBERWAND II (November 13, 2014)
  • K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (November 22, 1999)
  • K973251 — KSEA CALCUSON (June 22, 1998)
  • K920235 — ULTRASOUND GENERATOR MODLE 2270 (December 7, 1992)