510(k) · Cleared
ClearedModified Novy Cornual Cannulation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · MOV Catheters, Salpingography
Cleared on Jul 12, 2018 as substantially equivalent to K931476 (Cook Ob/Gyn, 1995) after a 133-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 12, 2018
- Review
- 133 days
- Class
- Class II
- Product code
- MOV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931476 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK931476 Novy Cornual Cannulation SetCook Ob/Gyn · 1995 · Recalled
- This deviceK180552 Modified Novy Cornual Cannulation SetCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931476 | Novy Cornual Cannulation Set | Cook Ob/Gyn | 1995 | 3 |
| 0 (this device) | K180552 | Modified Novy Cornual Cannulation Set | Cook Incorporated | 2018 | — |
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 MOV? 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? (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 |
|---|---|---|---|
| * | K931476 | Novy Cornual Cannulation SetSummary page 5…Page 2 of 3 The predicate device, the Novy Cornual Cannulation Set manufactured by Cook Incorporated (K931476), is a medical device set intended for use through the operating channel of a hysteroscope or other uterine access device, for hy… | 1995 |
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?
- Its one ancestor has a recall.
How does its category compare?
All MOV devicesMOV Catheters, Salpingography: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MOV
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MOV
Too few MOV 510(k)s in any year since 2007 to give a median.
Recalls per year · MOV
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOV
3in 2024
MAUDE reports naming product code MOV, 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 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 2 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Modified Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic or fluoroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation solution or contrast medium, in the evaluation of tubal patency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180552 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180552: Modified Novy Cornual Cannulation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180552
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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