Home / 510(k) Clearances / K241410

510(k) K241410

EDEN ControlCath by Jmt Co., Ltd. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2025
Date Received
May 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Jmt Co., Ltd.

  • K230762 — EDEN Spinal Fixation MIS System (June 15, 2023)
  • K201788 — EDEN Spinal Fixation System (June 23, 2022)
  • K201793 — EDEN Peek Cage (September 13, 2021)

Other clearances for product code BSO

  • 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)
  • K200624 — Percutaneous Introducer (April 27, 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)