# K964910: Aos Universal Connecting Guide Tube for High Dose Rate Afterloaders

- Pathway: 510(k) (Traditional)
- Applicant: Alpha-Omega Services, Inc.
- Decided: Mar 10, 1997 after 91 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 K881665 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881665: Omnitron Remote Controlled Radionuclide Applicator, Omnitron Intl., Inc. (1988) Summary page 1.

## Cited in the summary but kept off the family tree
- K962913: Synthes Sterile Drill Bits, Synthes (Usa) (1996). Our OCR of the scanned summary read K962913, FDA’s number for Synthes Sterile Drill Bits (Synthes (Usa)). Its FDA name has none of the distinctive words the summary uses for the device it names, “Varian Coupling Catheters”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K062824: Aos Universal Conecting Guide Tube (2007), 0 descendants of its own

## Indications for use
To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy.

Source page: https://510kreport.com/device/K964910
Methodology: https://510kreport.com/methodology