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510(k) K221893

KARL STORZ Bipolar Resectoscopes with HF Cable by Karl Storz Endoscopy America, Inc. — Product Code FJL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2023
Date Received
June 29, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K212458 — Flexible Video-Uretero-Renoscope SSU System (January 20, 2022)
  • K212656 — Flexible Intubation Video Endoscope – Sterile (FIVE-S) (December 29, 2021)
  • K212695 — KARL STORZ ICG Imaging System (November 15, 2021)

Other clearances for product code FJL

  • K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable (May 7, 2024)
  • K230205 — Veloxion System (February 24, 2023)
  • K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Velo (June 13, 2019)
  • K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Velo (March 15, 2019)
  • K162979 — Veloxion System (March 24, 2017)
  • K102663 — AED RESECTOSCOPE (December 30, 2010)
  • K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (March 22, 2007)
  • K042523 — RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSOR (March 18, 2005)
  • K041610 — MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (August 19, 2004)
  • K001270 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE (April 28, 2000)