# K040339: Brachytherapy Strand Device

- Pathway: 510(k) (Traditional)
- Applicant: Bebig Isotopen-Und Medizintechnik GmbH
- Decided: Apr 8, 2004 after 57 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: 3 generations back to K801748 (1980). 14 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982226: Uromed Brachytheraphy Iodine-125 Sources, Uromed Corp. (1999) Summary page 1.
- K021343: Isoseeds I-125, Bebig Isotopen-Und Medizintechnik GmbH (2002) Summary page 1.
- K010283: Theraseed (R) Palladium-103 Implant; Model 200, Theragenics Corp. (2001) Summary page 1.
- K944110: Vicryl Rapide Suture, ETHICON, Inc. (1995) Summary page 1.
- K030594: I-125 Rapid Strand, Model 7000, Amersham Health (2003) Summary page 2.

## Most influential descendants
- K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06 (2005), 9 descendants of its own
- 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

## Indications for use
The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics: o Localized o Unresectable o Low to Moderate Radiosensitivity The tumors may be of the following type: o Superficial o Intrathoracic o Intra-abdominal o Lung, Pancreas, Prostate, Head and Neck o Residual following external beam radiation or excision of primary tumor o Recurrent

Source page: https://510kreport.com/device/K040339
Methodology: https://510kreport.com/methodology