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Ez-Pak

by Ibt SA

510(k) K041702

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK041702 Date16 Jul 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Ez-Pak (Ez-Pak Is a Trademark of Ibt S.A.)
510(k) Number
FDA Product Code
KXK
Device Class
Class II
Regulation
21 CFR Part 892.5730
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ez-Pak is a packaging modification for existing brachytherapy sources, consisting of preloaded needles/cartridges containing sealed radioactive sources for interstitial implantation. It is a Class 2 medical device used in radiology.

The device is supplied with a product code of KXK and is regulated under regulation number 892.5730. It has been cleared by the FDA with a 510(k) number of K041702, with a decision date of 2004-07-16. The device is intended for use in radiology and has a device class of 2.

Other devices from Ibt, Inc.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the EZ-PAK serve?

    The EZ-PAK is designed as a packaging modification for existing brachytherapy sources. By delivering preloaded needles or cartridges that contain sealed radioactive sources, it enables clinicians to perform interstitial implantation procedures more efficiently and with reduced handling of individual sources, which is essential in radiology treatments.

  • How is the EZ-PAK supplied to the user?

    The device is supplied as preloaded needles or cartridges that already contain the sealed radioactive sources. This ready‑to‑use configuration eliminates the need for separate source loading steps, ensuring consistent placement and simplifying the workflow for interstitial brachytherapy procedures.

  • Is the EZ-PAK intended for single‑use or can it be reused?

    The EZ-PAK is provided as a preloaded, sealed system intended for a single implantation session. Because the radioactive sources are sealed within the cartridge, re‑sterilizing or reusing the unit could compromise both sterility and source integrity, so it is treated as a single‑use device.

  • What regulatory clearance does the EZ-PAK have?

    The EZ-PAK received FDA 510(k) clearance (K041702) on July 16 2004, classified as a Class 2 medical device under product code KXK and regulation number 892.5730. This clearance indicates it was found substantially equivalent to a legally marketed predicate device.

  • Are there different sizes or models of the EZ-PAK?

    The available data do not specify multiple sizes or model numbers for the EZ-PAK; it is described generally as a packaging modification for brachytherapy sources. If size variations exist, they would be defined by the specific needle or cartridge dimensions used for particular interstitial procedures.