# K200221: CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor

- Pathway: 510(k) (Special)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Feb 28, 2020 after 30 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: 5 generations back to K864210 (1986). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993472: Segmented Vaginal Applicator, Mick Radio-Nuclear Instruments, Inc. (2000) Summary page 7.
- K020176: HDR Miami Applicator, Mick Radio-Nuclear Instruments, Inc. (2002) Summary page 7.
- K040704: Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix Applicator, Mick Radio-Nuclear Instruments, Inc. (2004) Summary page 7.
- K063381: CT Compatible F/S/D Applicators, Mick Radio-Nuclear Instruments, Inc. (2006) Summary page 7.
- K063382: HDR CT Compatible Split Ring Applicator, Mick Radio-Nuclear Instruments, Inc. (2006) Summary page 7.
- K122840: CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407, Mick Radio-Nuclear Instruments, Inc. (2012) Summary page 7.
- K871216: Hilaris-Nori Endometrial Applicator, Mick Radio-Nuclear Instruments, Inc. (1987) Summary page 7.

## Indications for use
2/3 Endometrial Applicator Sets: A manual radionuclide applicator system, a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Segmented Vaginal Applicator: The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modem era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors are now treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities of this are Low Dose Rate and High Dose Rate remote afterloading (Brachytherapy). One common use of Brachytherapy is in the treatment of cancer of the vaginal process. The system described in this 510(k) has been developed to function as an applicator for the positioning of sealed sources in the intracavitary treatment of the vagina. HDR Miami Applicator: This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891l3l /A) which uses a single radioactive source of lridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diameter sleeves and intrauterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa. HDR Compatible Tandem and Ovoid Applicators: The applicators presented in this 510(k) notification have been developed to function as Applicators for the positioning of HDR Remote After-Loader sealed sources in the intra-cavitary treatment of cancer of the vagina and cervix. CT Compatible F/S/D Applicators: CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice. HDR CT Compatible Split Ring Applicator: The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice. CCT HDR Tandem Ring Applicator with Rectal Retractor: The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.

Source page: https://510kreport.com/device/K200221
Methodology: https://510kreport.com/methodology