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Burbank Tenaculum, Model 09-0011-01

by Vascular Control Systems, Inc.

510(k) K030078

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030078 Date24 Jan 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HDC
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Burbank Tenaculum, model 09-0011-01, is a uterine tenaculum designed for use in obstetrics and gynecology procedures. It functions as an accessory to the Vascular Control Systems Transvaginal Doppler Probe, intended to seize and hold the cervix to secure the probe in place during audible Doppler procedures.

This device is regulated under FDA 510(k) clearance K030078. It is classified under regulation number 884.4530 and falls under the product code HDC.

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