# K233628: AOS Interstitial Templates, Needles, and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Alpha-Omega Services, Inc.
- Decided: Jul 10, 2024 after 240 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 K062823 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062823: Aos Interstitial Templates, Needles & Accessories, Alpha-Omega Services, Inc. (2007) Summary page 4.

## Indications for use
AOS Interstitial Templates, Needles, and Accessories are indicated for use in adults where Brachytherapy of the cervix or prostate is an accepted clinical practice.

Source page: https://510kreport.com/device/K233628
Methodology: https://510kreport.com/methodology