510(k) · Cleared
ClearedStargate Falloposcopy Catheter, Trifurcated Irrigation Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conceptus, Inc. · MKO Falloposcope
Cleared on Jan 21, 1998 after a 90-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 21, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- MKO
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MKO? 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 MKO device
- #1 K221965 FemDx FalloViewscore 5.0 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Conceptus VS™ Catheter Named without a submission number | |
| * | — | Clarus Medical, Model 5150 Tubing Set Named without a submission number |
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 MKO devicesMKO Falloposcope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MKO
Too few MKO 510(k)s in any year since 2007 to give a median.
Recalls per year · MKO
No recall names MKO since 2007.
Adverse event reports per year · MKO
No MAUDE report names MKO since 2007.
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 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The STARRT System is indicated for use as a secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography. The STARRT System is only designed to access the proximal portion of the fallopian tube, i.e. the first 2-3 cm. It should only be advanced as far as necessary to achieve a meaningful study, recognizing that possible adverse effects of more distal…
Read the full statement (141 words)
The STARRT System is indicated for use as a secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography.
The STARRT System is only designed to access the proximal portion of the fallopian tube, i.e. the first 2-3 cm. It should only be advanced as far as necessary to achieve a meaningful study, recognizing that possible adverse effects of more distal advancement, particularly upon normal tubes, have not yet been determined.
The STARRT System is not intended for tubal recanalization, and there is no data available, in particular, pregnancy data, showing clinical benefit for this use. Studies are underway.
The STARRT System is not to be used for gamete or embryo transfer, or other assisted reproduction techniques.
The STARRT System should only be used by clinicians with experience in tubal evaluation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974028: Stargate Falloposcopy Catheter, Trifurcated Irrigation Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974028
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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