# K151657: Shielded Applicator Set, Cervical Stop

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Aug 7, 2015 after 49 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 K912555 (1991). 3 ancestors in all.
1 later device descends 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)
- K033371: Varian Intracavitary Brachytherapy Applicators, Varian Medical Systems (2003) Summary page 4.
- (no number) Cervix Applicator Set, Cervical Stopper: named in the summary without a submission number

## Most influential descendants
- K240495: Flexible Fixation Device for Gynecological Applicators (GM11001960) (2024), 0 descendants of its own

## Indications for use
The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginal stump or rectum where partial shielding is required using HDR or PDR Brachytherapy. The Cervical Stop is indicated for use with Varian metallic intrauterine tandems/probes to provide a physical stop for depth of insertion of these applicators within the uterus during HDR or PDR brachytherapy.

Source page: https://510kreport.com/device/K151657
Methodology: https://510kreport.com/methodology