# K160610: Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set

- Pathway: 510(k) (Traditional)
- Applicant: Kobold, LLC
- Decided: Feb 13, 2017 after 347 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: 4 generations back to K912555 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123912: Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set, Spencer Fillmore (2013) Summary page 7.
- K123941: Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder Set, Spencer Fillmore (2013) Summary page 7.

## Indications for use
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-to-date clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient. The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Henschke type applicator is accepted by up-to-date clinical guidelines. The Kobold® Henschke-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient. The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the vagina is accepted by up-to-date clinical guidelines. The Kobold® Vaginal Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient. The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set is indicated for use in any patient case where high dose rate (HDR) radiation treatment of the cervix, vagina, and uterus with a Miami type applicator is acceptable by up-to-date clinical guidelines. The Kobold® Miami Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.

Source page: https://510kreport.com/device/K160610
Methodology: https://510kreport.com/methodology