# K150504: GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor

- Pathway: 510(k) (Traditional)
- Applicant: Pci Medical, Inc.
- Decided: Nov 16, 2015 after 263 days
- Product code: PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914145 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051305: CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant, Model TD-5, Cs Medical, LLC (2005) Summary page 5.

## Most influential descendants
- K163313: ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor (2017), 0 descendants of its own

## Indications for use
The GUS ASTRA TEE™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants. The GUS ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.

Source page: https://510kreport.com/device/K150504
Methodology: https://510kreport.com/methodology