# K081677: Savi Applicator Kit

- Pathway: 510(k) (Special)
- Applicant: Cianna Medical, Inc.
- Decided: Jul 22, 2008 after 35 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: 7 generations back to K864210 (1986). 15 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080565: Modification to: Savi Applicator Kit, Cianna Medical, Inc. (2008) Summary page 1.
- K980601: Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader, Varian Assoc., Inc. (1998) Summary page 1.
- K032372: Nucletron Comfort Catheter System, Model 189.007, Nucletron Corporation (2003) Summary page 1.
- K033371: Varian Intracavitary Brachytherapy Applicators, Varian Medical Systems (2003) Summary page 1.

## Most influential descendants
- K091378: Mammosite II Radiation Therapy System (2009), 9 descendants of its own
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), 8 descendants of its own
- K133655: Radiance V2 (2014), 5 descendants of its own
- K153368: Radiance V3 (2016), 4 descendants of its own
- K171885: Radiance V4 (2017), 3 descendants of its own

## Indications for use
The SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Source page: https://510kreport.com/device/K081677
Methodology: https://510kreport.com/methodology