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510(k) K973251

KSEA CALCUSON by KARL STORZ Endoscopy-America, Inc. — Product Code FEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1998
Date Received
August 29, 1997
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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Other clearances for product code FEO

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  • 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)
  • K920235 — ULTRASOUND GENERATOR MODLE 2270 (December 7, 1992)
  • K873367 — OLYMPUS LUS ULTRASONIC LITHOTRIPTER (November 30, 1987)