Transvaginal Ultrasound Probe Holder Device
FDA 510(k) K992071 · Ron-Tech Medical , Ltd.
510(k) numberK992071
Submission
- Device name
- Transvaginal Ultrasound Probe Holder Device
- Applicant
- Ron-Tech Medical , Ltd.
Ginot, Shomron, IL - Received
- June 18, 1999
- Decision date
- August 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HDC – Tenaculum, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K030078 | Burbank Tenaculum, Model 09-0011-01HDC · Traditional | Vascular Control Systems, Inc. | 01/24/2003SE |
| K001818 | Uterine Tenaclum HookHDC · Traditional | Towne Brothers (Pvt.), Ltd. | 08/30/2000SE |
More from Towne Brothers (Pvt.), Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K032585 | Transvaginal Ultrasound Probe Holder SystemHDC · Special | 01/09/2004SE |
Questions and answers
When was Transvaginal Ultrasound Probe Holder Device cleared by the FDA?
Transvaginal Ultrasound Probe Holder Device (K992071) received a 510(k) decision of Substantially Equivalent on August 27, 1999, 70 days after the submission was received.
What is the product code of K992071?
The FDA product code is HDC – Tenaculum, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.