# K123912: Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set

- Pathway: 510(k) (Traditional)
- Applicant: Spencer Fillmore
- Decided: May 14, 2013 after 146 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: 3 generations back to K864210 (1986). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011657: HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments, Inc. (2001)

## Most influential descendants
- 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 (2017), 0 descendants of its own
- K142330: Kobold Ring and Tandem Applicator Set (2015), 0 descendants of its own

## Indications for use
The CT/MRI Compatible HDR Fletcher Type Applicator is indicated for use in any, case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by tip-to-date clinical guidelines.

Source page: https://510kreport.com/device/K123912
Methodology: https://510kreport.com/methodology