# K041702: EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)

- Pathway: 510(k) (Special)
- Applicant: Ibt SA
- Decided: Jul 16, 2004 after 24 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K874787 (1987). 5 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973328: Intersource, International Brachytherapy S.A. (1998) Summary page 1.
- K984235: Intersource 125, Model 1251L, International Brachytherapy, Inc. (1999) Summary page 1.
- K011155: Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S, Ibt, Inc. (2001)

## Most influential descendants
- K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge (2006), 7 descendants of its own
- K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 (2009), 4 descendants of its own
- K180515: GammaTile (2018), 3 descendants of its own
- K190296: GammaTile (2019), 2 descendants of its own
- K190839: GammaTile (2020), 1 descendant of its own

## Indications for use
The sources in EZ-Pak Preloaded Needles are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. The source in EZ-Pak Preloaded Needles are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

Source page: https://510kreport.com/device/K041702
Methodology: https://510kreport.com/methodology