# K033828: CT Compatible Intrauterine Sleeves, Cat #0311, 9406

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Feb 2, 2004 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: 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 1.

## Indications for use
The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading (Brachytherapy). One common application of Brachytherapy is in the treatment of cancer of the cervix. This accessory for cervical applicators is designed as an accessory for any Cervical Applicator that has a non-curved tandem. Use of the Intrauterine Sleeve aids in repeated insertion of the cervical applicator during fractionated treatments, eliminating repeated use of anesthesia and prevents the possibility of uterine perforation.

Source page: https://510kreport.com/device/K033828
Methodology: https://510kreport.com/methodology