# K172533: GM Implant Tubes, Length Cutting Gauge

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Oct 22, 2018 after 426 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 K912555 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System, Gammamed USA (1998) Summary page 4.

## Indications for use
The GM Implant Tubes is indicated for use for irradiation treatments which require a flexible source guiding lumen including treatments of the head, neck, tongue, bladder, gynecology and prostate using HDR or PDR brachytherapy. The Length Cutting Gauge in its variable length is indicated for use to cut implant tube or breast applicator treatment channels to the correct treatment length.

Source page: https://510kreport.com/device/K172533
Methodology: https://510kreport.com/methodology