# K101411: Savi Preparation Device

- Pathway: 510(k) (Traditional)
- Applicant: Cianna Medical, Inc.
- Decided: Jul 12, 2010 after 54 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092323: Contura Cavity Maintenance Catheter, Senorx, Inc. (2009) Summary page 1.
- K081179: Mammosite Cavity Evaluation Device, Hologic, Inc. (2008) Summary page 1.

## Indications for use
The SAVI Preparation Device is temporarily implanted in the lumpectomy to access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytherapy applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator.

Source page: https://510kreport.com/device/K101411
Methodology: https://510kreport.com/methodology