Burbank Tenaculum

FDA 510(k) K060573 · Vascular Control Systems, Inc.

Substantially Equivalent

510(k) numberK060573

Submission

Device name
Burbank Tenaculum
Applicant
Vascular Control Systems, Inc.
San Juan Capistrano, CA, US
Received
March 6, 2006
Decision date
April 21, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
HDC – Tenaculum, Uterine
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

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K142204Bioceptive Suction Cervical RetractorHDC · Traditional Bioceptive, Inc.12/19/2014SE
K082349Jarit Hulka Uterine Tenaculum ForcepsHDC · Traditional J. Jamner Surgical Instruments, Inc.11/21/2008SE
K073182Gyn Disposables Tenaculum 356THDC · Traditional Gyn-Disposables, Inc.11/28/2007SE
K062563Femten Cervical TenaculumHDC · Traditional Fem Suite, LLC05/18/2007SE
K032585Transvaginal Ultrasound Probe Holder SystemHDC · Special Ron-Tech Medical , Ltd.01/09/2004SE
K030078Burbank Tenaculum, Model 09-0011-01HDC · Traditional Vascular Control Systems, Inc.01/24/2003SE
K001818Uterine Tenaclum HookHDC · Traditional Towne Brothers (Pvt.), Ltd.08/30/2000SE
K992071Transvaginal Ultrasound Probe Holder DeviceHDC · Traditional Ron-Tech Medical , Ltd.08/27/1999SE

More from Ron-Tech Medical , Ltd.

510(k)DeviceDecision
K052209VCS Doppler Transceiver, Model 09-0023-01DPW · Traditional 09/06/2005SE
K032125Cstat, Models 09-0014-01 and 09-0014-02DXC · Traditional 02/09/2004SE
K031812Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03DXC · Traditional 12/12/2003SE
K031358Transvaginal Doppler ProbeITX · Traditional 05/09/2003SE
K030078Burbank Tenaculum, Model 09-0011-01HDC · Traditional 01/24/2003SE
K023154Vcs-A Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02DXC · Traditional 12/20/2002SE
K023024Transvaginal Doppler Probe, Model 09-0006-02ITX · Traditional 09/26/2002SE
K011863Vcs-A Series ClampDXC · Traditional 02/15/2002SE

Questions and answers

When was Burbank Tenaculum cleared by the FDA?

Burbank Tenaculum (K060573) received a 510(k) decision of Substantially Equivalent on April 21, 2006, 46 days after the submission was received.

What is the product code of K060573?

The FDA product code is HDC – Tenaculum, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.