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510(k) K230205

Veloxion System by Corinth Medtech, Inc. — Product Code FJL

K230205 is an FDA 510(k) premarket notification submitted by Corinth Medtech, Inc. for the device "Veloxion System". The FDA issued a decision of Substantially Equivalent on February 24, 2023. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. Corinth Medtech, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2023
Date Received
January 25, 2023
Clearance Type
Special
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

Other clearances by Corinth Medtech, Inc.

  • K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Velo (June 13, 2019)
  • K191335 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Velo (June 6, 2019)
  • K190113 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Velo (April 24, 2019)
  • K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Velo (March 15, 2019)
  • K180752 — Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxio (July 25, 2018)
  • K162979 — Veloxion System (March 24, 2017)

Other clearances for product code FJL

  • K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable (May 7, 2024)
  • K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 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)

FDA data resources