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510(k) K062918

KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM by KARL STORZ Endoscopy-America, Inc. — Product Code FBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2007
Date Received
September 28, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystourethroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by KARL STORZ Endoscopy-America, Inc.

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  • K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver (October 22, 2020)
  • K201135 — Image1 S CCU, Image1 S 4U Camera Head (September 1, 2020)
  • K200740 — HD Video Rhino Laryngoscope (August 11, 2020)
  • K191357 — Flexible HD Cysto-Urethroscope System (September 18, 2019)
  • K182723 — Flexible HD Cysto-Urethroscope System (April 23, 2019)
  • K182186 — CMOS Video-Rhino-Laryngoscope System (March 22, 2019)
  • K183264 — Flex-THOR scope (January 18, 2019)
  • K182696 — Telepack X LED (November 20, 2018)

Other clearances for product code FBO

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  • K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (November 27, 2024)
  • K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE (January 2, 2014)
  • K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND C (October 10, 2008)
  • K080780 — ANCHORAGE SCOPE, MODEL 000003 (July 30, 2008)
  • K061646 — LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES (June 27, 2006)
  • K011496 — CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENT (August 10, 2001)
  • K972979 — SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RI (December 11, 1997)
  • K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (December 20, 1996)
  • K941992 — CYSTOSCOPE (November 30, 1995)