510(k) · Cleared
ClearedSingle Channel Balloon Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conkin Surgical Instruments, Ltd. · HDP Elevator, Uterine
Cleared on Jul 9, 1998 after a 199-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 9, 1998
- Review
- 199 days
- Class
- Class II
- Product code
- HDP
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HDP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All HDP devicesHDP Elevator, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDP
FDA has decided no HDP device since 2007.
Median 510(k) review, days · HDP
Too few HDP 510(k)s in any year since 2007 to give a median.
Recalls per year · HDP
No recall names HDP since 2007.
Adverse event reports per year · HDP
1in 2020
MAUDE reports naming product code HDP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SINGLE CHANNEL BALLOON CANNULA is to be used with the VALTCHEV UTERINE MOBILIZER, models VUM-4 or VUM-5, for mobilization of the uterus and injection of dye. It is indicated for use during those procedures requiring manipulation of the uterus such as a minilap, laparoscopic tubal occlusion or diagnostic and operative laparoscopy. It is also an efficient intrauterine injector that effectively seals the internal cervical os against the cervical backflow of fluid during its injection through the device’s central lumen and as such can be used in laparoscopic tubal patency studies and, in selected patients, for such procedures as hysterosalpingography.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974801: Single Channel Balloon Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974801
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026