EDEN ControlCath

FDA 510(k) K241410 · Jmt Co., Ltd.

Substantially Equivalent

510(k) numberK241410

Submission

Device name
EDEN ControlCath
Applicant
Jmt Co., Ltd.
Yangju-Si, KR
Received
May 17, 2024
Decision date
February 13, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSO – Catheter, Conduction, Anesthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5120
Specialty
Anesthesiology

Other 510(k)s with product code BSO

510(k)DeviceApplicantDecision
K231242Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional B.Braun Medical, Inc.09/15/2023SE
K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional Teleflex Medical08/30/2023SE
K193664SubQKath Catheter and Needle SetBSO · Traditional Hk Surgical09/09/2020SE
K200624Percutaneous IntroducerBSO · Traditional Epimed International, Inc.04/27/2020SE
K191470C-CAT Anaesthesia Catheter kitBSO · Traditional Cimpax Aps10/25/2019SE
K181782Medline Reinforced Epidural CatheterBSO · Traditional Medline Industries, Inc.03/04/2019SE
K173541EpinautBSO · Traditional Imedicom Co., Ltd.08/24/2018SE
K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional PAJUNK GmbH Medizintechnologie05/03/2018SE
K171584B. Braun Tear-Away Introducer NeedleBSO · Traditional B.Braun Medical, Inc.12/22/2017SE
K171193Certa CatheterBSO · Traditional Ferrosan Medical Devices Sp. Z.O.O.12/18/2017SE

More from Ferrosan Medical Devices Sp. Z.O.O.

510(k)DeviceDecision
K230762EDEN Spinal Fixation MIS SystemNKB · Special 06/15/2023SE
K201788EDEN Spinal Fixation SystemNKB · Traditional 06/23/2022SE
K201793EDEN Peek CageODP · Traditional 09/13/2021SE

Questions and answers

When was EDEN ControlCath cleared by the FDA?

EDEN ControlCath (K241410) received a 510(k) decision of Substantially Equivalent on February 13, 2025, 272 days after the submission was received.

What is the product code of K241410?

The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.