# K160815: Interstitial Needles

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 10, 2017 after 351 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: 3 generations back to K952913 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093291: Varian Interstitial Titanium Needles, Varian Medical Systems, Inc. (2009) Summary page 4.

## Indications for use
The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue.

Source page: https://510kreport.com/device/K160815
Methodology: https://510kreport.com/methodology