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FDA 510(k)

EDEN ControlCath

K-Number: K241410 · 2025-02-13

ApplicantJmt Co., Ltd.
Decision Date2025-02-13
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EDEN ControlCath is a medical device manufactured by Jmt Co., Ltd.. It received FDA 510(k) clearance on 2025-02-13 under approval number K241410. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDEN ControlCath?

EDEN ControlCath is a medical device that received FDA 510(k) clearance on 2025-02-13. It is manufactured by Jmt Co., Ltd.. The 510(k) number is K241410.

When was EDEN ControlCath approved by the FDA?

EDEN ControlCath received FDA 510(k) clearance on 2025-02-13, under approval number K241410.

What company makes EDEN ControlCath?

EDEN ControlCath is manufactured by Jmt Co., Ltd..

What is the FDA product code for EDEN ControlCath?

The FDA product code for EDEN ControlCath is BSO.

Other Devices by Jmt Co., Ltd.

K201793EDEN Peek Cage K201788EDEN Spinal Fixation System K230762EDEN Spinal Fixation MIS System

Related Devices (Code: BSO)

K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health K153297Perifix and Contiplex CatheterB.Braun Medical, Inc. K152952E-CathPAJUNK GmbH Medizintechnologie K150731Medline Epidural CatheterMedline Industries, Inc. K150789SPINAUT-E, SPINAUT-IImedicom Co., Ltd. K171584B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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