Cleared Traditional

EDEN ControlCath

K241410 · Jmt Co., Ltd. · Anesthesiology
Feb 2025
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K241410 is an FDA 510(k) clearance for the EDEN ControlCath, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Jmt Co., Ltd. (Yangju-Si, KR). The FDA issued a Cleared decision on February 13, 2025, 272 days after receiving the submission on May 17, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K241410 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2024
Decision Date February 13, 2025
Days to Decision 272 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

Similar Devices — BSO Catheter, Conduction, Anesthetic

All 74
Perifix FX Catheter; Contiplex FX Catheter
K231242 · B.Braun Medical, Inc. · Sep 2023
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
K230603 · Teleflex Medical · Aug 2023
SubQKath Catheter and Needle Set
K193664 · Hk Surgical · Sep 2020
Percutaneous Introducer
K200624 · Epimed International, Inc. · Apr 2020
C-CAT Anaesthesia Catheter kit
K191470 · Cimpax Aps · Oct 2019
Medline Reinforced Epidural Catheter
K181782 · Medline Industries, Inc. · Mar 2019