510(k) · Cleared
ClearedBurbank Tenaculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Control Systems, Inc. · HDC Tenaculum, Uterine
Cleared on Apr 21, 2006 as substantially equivalent to K030078 (Vascular Control Systems, Inc., 2003) after a 46-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Apr 21, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- HDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992071 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HDC device
- #1 K223866 Carevix™ Suction Cervical Stabilizerscore 5.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030078 | Burbank Tenaculum, Model 09-0011-01Summary page 1…d: Company: Vascular Control Systems, Inc. Device: Burbank Tenaculum 5 10(k): K030078 Date Cleared: January 24, 2003 4. A description of the device that is the subject of the 510(k), i… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All HDC devicesHDC Tenaculum, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HDC
Too few HDC 510(k)s in any year since 2007 to give a median.
Recalls per year · HDC
6in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HDC
5in 2022
MAUDE reports naming product code HDC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 6 | 4 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060573: Burbank Tenaculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060573
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026