# K983338: Freiburg Flap Applicator Set, Part Number 089.095

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Apr 20, 1999 after 209 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: 1 generation back to K961601 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961601: H.a.M. Applicator, Mick Radio-Nuclear Instruments, Inc. (1996) Summary page 1.

## Most influential descendants
- K060299: Art Brachytherapy Applicator (2006), 1 descendant of its own
- K062135: Art Shielded Breast Applicator (2006), 0 descendants of its own

## Indications for use
Nucletron Frieburg Flap Applicator Set is intended for skin surface or intraoperative brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

Source page: https://510kreport.com/device/K983338
Methodology: https://510kreport.com/methodology