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510(k) K200624

Percutaneous Introducer by Epimed International, Inc. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2020
Date Received
March 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type

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  • K072005 — RK EPIDURAL NEEDLE (February 7, 2008)
  • K053318 — RX EPIDURAL NEEDLE (February 17, 2006)
  • K051171 — STINGRAY EPIDURAL CATHETER CONNECTOR (August 26, 2005)
  • K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 (August 22, 2005)
  • K043467 — FLEXIBLE SPINAL NEEDLE (March 31, 2005)
  • K041021 — RF INTRODUCTION CANNULA (September 16, 2004)
  • K041843 — PENCIL POINT NEEDLE (August 24, 2004)

Other clearances for product code BSO

  • K241410 — EDEN ControlCath (February 13, 2025)
  • K231242 — Perifix FX Catheter; Contiplex FX Catheter (September 15, 2023)
  • K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Nex (August 30, 2023)
  • K193664 — SubQKath Catheter and Needle Set (September 9, 2020)
  • K191470 — C-CAT Anaesthesia Catheter kit (October 25, 2019)
  • K181782 — Medline Reinforced Epidural Catheter (March 4, 2019)
  • K173541 — EPINAUT (August 24, 2018)
  • K172777 — Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (May 3, 2018)
  • K171584 — B. Braun Tear-Away Introducer Needle (December 22, 2017)
  • K171193 — Certa Catheter (December 18, 2017)