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510(k) K180752

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole by Corinth Medtech, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2018
Date Received
March 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Corinth Medtech, Inc.

  • K230205 — Veloxion System (February 24, 2023)
  • 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)
  • K162979 — Veloxion System (March 24, 2017)

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  • K231260 — HTx Disposable Hysteroscope System (March 5, 2024)
  • K233635 — SPY Cystoscope/Hysteroscope (February 12, 2024)
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