Burbank Tenaculum, Model 09-0011-01
FDA 510(k) K030078 · Vascular Control Systems, Inc.
510(k) numberK030078
Submission
- Device name
- Burbank Tenaculum, Model 09-0011-01
- Applicant
- Vascular Control Systems, Inc.
San Juan Capistrano, CA, US - Received
- January 9, 2003
- Decision date
- January 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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|---|---|---|---|
| K223866 | Carevix Suction Cervical StabilizerHDC · Special | Aspivix SA | 01/25/2023SE |
| K203820 | ASPIVIX v1.1 Cervical Suction TenaculumHDC · Traditional | Aspivix SA | 08/17/2021SE |
| K142204 | Bioceptive Suction Cervical RetractorHDC · Traditional | Bioceptive, Inc. | 12/19/2014SE |
| K082349 | Jarit Hulka Uterine Tenaculum ForcepsHDC · Traditional | J. Jamner Surgical Instruments, Inc. | 11/21/2008SE |
| K073182 | Gyn Disposables Tenaculum 356THDC · Traditional | Gyn-Disposables, Inc. | 11/28/2007SE |
| K062563 | Femten Cervical TenaculumHDC · Traditional | Fem Suite, LLC | 05/18/2007SE |
| K060573 | Burbank TenaculumHDC · Traditional | Vascular Control Systems, Inc. | 04/21/2006SE |
| K032585 | Transvaginal Ultrasound Probe Holder SystemHDC · Special | Ron-Tech Medical , Ltd. | 01/09/2004SE |
| K001818 | Uterine Tenaclum HookHDC · Traditional | Towne Brothers (Pvt.), Ltd. | 08/30/2000SE |
| K992071 | Transvaginal Ultrasound Probe Holder DeviceHDC · Traditional | Ron-Tech Medical , Ltd. | 08/27/1999SE |
More from Ron-Tech Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K060573 | Burbank TenaculumHDC · Traditional | 04/21/2006SE |
| K052209 | VCS Doppler Transceiver, Model 09-0023-01DPW · Traditional | 09/06/2005SE |
| K032125 | Cstat, Models 09-0014-01 and 09-0014-02DXC · Traditional | 02/09/2004SE |
| K031812 | Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03DXC · Traditional | 12/12/2003SE |
| K031358 | Transvaginal Doppler ProbeITX · Traditional | 05/09/2003SE |
| K023154 | Vcs-A Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02DXC · Traditional | 12/20/2002SE |
| K023024 | Transvaginal Doppler Probe, Model 09-0006-02ITX · Traditional | 09/26/2002SE |
| K011863 | Vcs-A Series ClampDXC · Traditional | 02/15/2002SE |
Questions and answers
When was Burbank Tenaculum, Model 09-0011-01 cleared by the FDA?
Burbank Tenaculum, Model 09-0011-01 (K030078) received a 510(k) decision of Substantially Equivalent on January 24, 2003, 15 days after the submission was received.
What is the product code of K030078?
The FDA product code is HDC – Tenaculum, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.