# K992071: Transvaginal Ultrasound Probe Holder Device

- Pathway: 510(k) (Traditional)
- Applicant: Ron-Tech Medical, Ltd.
- Decided: Aug 27, 1999 after 70 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030078: Burbank Tenaculum, Model 09-0011-01 (2003), 1 descendant of its own
- K060573: Burbank Tenaculum (2006), 0 descendants of its own
- K032585: Transvaginal Ultrasound Probe Holder System (2004), 0 descendants of its own

## Indications for use
The Transvaginal Ultrasound Probe Holder device is an accessory used in conjunction with a transvaginal ultrasound transducer. The device 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/K992071
Methodology: https://510kreport.com/methodology