# K133922: Gentlecare AR Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Gc Medtech, LLC
- Decided: Apr 18, 2014 after 116 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: 6 generations back to K864210 (1986). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092822: Capri Applicator, Vivaray, Inc. (2009) Summary page 1.

## Indications for use
The GentleCare.AR.Applicator is Intended for use during bn chy therapy procedures. The multiple lumens, of the GC Med[Tech device are intended to provide pathways fromt which a prescribed radiation dose is delivered to the treatment area -

Source page: https://510kreport.com/device/K133922
Methodology: https://510kreport.com/methodology