# K130757: Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Spencer Fillmore
- Decided: Apr 3, 2014 after 379 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- 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 K811279 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113766: Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter Transfer Guide Tube Set Varisource Luer Tran, Varian Medical Systems, Inc. (2012) Summary page 4.
- K051423: Mick HDR Interstitial Implant Accessories, Mick Radio-Nuclear Instruments, Inc. (2005) Summary page 6.

## Indications for use
The Secure Lock transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. Transfer guide tubes are non-invasive products that have no direct patient contact. The Luer transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators that include a Luer style connection. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. Transfer guide tubes are non-invasive products that have no direct patient contact. The Luer interstitial extenders have been developed to enable the connection of Luer transfer guide tube to Kobold Interstitial Needles. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. Interstitial extenders are non-invasive products that have no direct patient contact.

Source page: https://510kreport.com/device/K130757
Methodology: https://510kreport.com/methodology