# K032585: Transvaginal Ultrasound Probe Holder System

- Pathway: 510(k) (Special)
- Applicant: Ron-Tech Medical, Ltd.
- Decided: Jan 9, 2004 after 141 days
- Product code: HDC (Tenaculum, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 K992071 (1999). 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)
- K992071: Transvaginal Ultrasound Probe Holder Device, Ron-Tech Medical, Ltd. (1999) Summary page 1.

## Indications for use
The SafeTChoiceTM Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoiceTM Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing Sonographic procedures.

Source page: https://510kreport.com/device/K032585
Methodology: https://510kreport.com/methodology