# K011657: HDR Tandem/Ring Applicator with Rectal Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Aug 27, 2001 after 90 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864210 (1986). 3 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.

## Most influential descendants
- K030110: CT HDR Tandem/Ring Applicator with Rectal Retractor (2003), 9 descendants of its own
- K150839: 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 (2015), 2 descendants of its own
- K123912: Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set (2013), 2 descendants of its own
- K122840: CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407 (2012), 2 descendants of its own
- K063382: HDR CT Compatible Split Ring Applicator (2006), 2 descendants of its own

## Recalls of this device
- Apr 12, 2012 · Class II · Z-0760-2013: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
- Apr 12, 2012 · Class II · Z-0759-2013: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

## 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 applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The HDR Tandem/Ring Applicator with Rectal Retractor is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Ring Applicator, K953946) and with a rectal retractor and varying intrauterine tube length diameters, clinical needs can be best optimized along with minimization of dose to the rectum.

Source page: https://510kreport.com/device/K011657
Methodology: https://510kreport.com/methodology