# K030078: Burbank Tenaculum, Model 09-0011-01

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Control Systems, Inc.
- Decided: Jan 24, 2003 after 15 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.
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)
- K992071: Transvaginal Ultrasound Probe Holder Device, Ron-Tech Medical, Ltd. (1999) Summary page 1.
- (no number) Sims Uterine Sound: named in the summary without a submission number

## Most influential descendants
- K060573: Burbank Tenaculum (2006), 0 descendants of its own

## Indications for use
The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

Source page: https://510kreport.com/device/K030078
Methodology: https://510kreport.com/methodology