# K172675: Varian Cervical Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: May 16, 2018 after 253 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 K913908 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955844: Applicators for Varian Varisource Remote High Dose Rate Afterloader, Varian Assoc., Inc. (1996) Summary page 4.

## Indications for use
The Varian Cervical Sleeves are intended for use for treatment of any case where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.

Source page: https://510kreport.com/device/K172675
Methodology: https://510kreport.com/methodology