# K060573: Burbank Tenaculum

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Control Systems, Inc.
- Decided: Apr 21, 2006 after 46 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: 2 generations back to K992071 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030078: Burbank Tenaculum, Model 09-0011-01, Vascular Control Systems, Inc. (2003) Summary page 1.

## Indications for use
The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostatTM Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures. This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.

Source page: https://510kreport.com/device/K060573
Methodology: https://510kreport.com/methodology