# K120341: Plastic Needle with Mandrin 2.0 Diameter Length 113MM

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Apr 27, 2012 after 84 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 K871217 (1987). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980590: Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose Rate Afterloader, Varian Medical Systems, Inc. (1998) Summary page 2.

## Most influential descendants
- K141624: Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle with Mandrin, 2.0 MM Diameter, Length 113 (2015), 1 descendant of its own
- K152018: Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets (2015), 0 descendants of its own

## Indications for use
The Interstitial Plastic Needles arte designed for interstitial brachytherapy treatments in areas such as the head and neck, gynecological, breast and prostate.

Source page: https://510kreport.com/device/K120341
Methodology: https://510kreport.com/methodology