510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Novy Cornual Cannulation Set

K931476510(k) TraditionalCleared Jul 28, 1995856-day reviewClass II21 CFR 884.4530Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Ob/Gyn · MOV Catheters, Salpingography

Cleared on Jul 28, 1995 after an 856-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 3 times.

Decided
Jul 28, 1995
Review
856 days
Class
Class II
Product code
MOV
Recalls
3
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared1995200020052010201520202025
  1. This deviceK931476 Novy Cornual Cannulation SetCook Ob/Gyn · 1995
  2. Descendant · cites it directly · 0 of its ownK180552 Modified Novy Cornual Cannulation SetCook Incorporated · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K180552Modified Novy Cornual Cannulation SetCook Incorporated · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931476Novy Cornual Cannulation SetCook Ob/Gyn1995—
+1K180552Modified Novy Cornual Cannulation SetCook Incorporated2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K931476, 1995–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180552Modified Novy Cornual Cannulation SetCook Incorporated20180

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 15, 2016Class IIZ-2621-2016Unknown/Undetermined by firmIncrease in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or…
Jan 8, 2010Not classifiedZ-1138-2010Process controlThe distal tip may separate from the catheter while the catheter is in the patient.
Jan 8, 2010Not classifiedZ-1137-2010Process controlThe distal tip may separate from the catheter while the catheter is in the patient.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K180552 (Cook Incorporated, 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MOV devices

MOV Catheters, Salpingography: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOV

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

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

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOV

3in 2024

2008: 12009: 12010: 12011: 12014: 12015: 22018: 22019: 12020: 22021: 12024: 3
2007high 3 (2024) · low 0 (2007)2025

MAUDE reports naming product code MOV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—01
20100—21
20110—01
20120—00
20130—00
20140—01
20150—02
20160—00
20170—00
20181—02
20190—01
20200—02
20210—01
20220—00
20230—00
20240—03
20250—00
20260—0—

More from Cook Ob/Gyn

43 FDA decisions under this applicant name. See the company

  • K062438Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
  • K030441Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitCook Ob/Gyn · 2003
  • K023850Sydney Ivf Embryo Biopsy MediumCook Ob/Gyn · 2003
  • K013597Tamponade Uterine Balloon Catheter SetCook Ob/Gyn · 2002
  • K002385Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf…Cook Ob/Gyn · 2000

Recent decisions in MOV

The MOV category page

  • K180552Modified Novy Cornual Cannulation SetCook Incorporated · 2018
  • K932436Echomark Intrauterine Guiding CatheterEchocath, Inc. · 1995
  • K931534Ovamed Intrauterine Access CatheterOvamed Corp. · 1995
  • K953314Conceptus Fallopian Tube Catheterization SystemConceptus, Inc. · 1995

https://510kreport.com/device/K931476 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931476: Novy Cornual Cannulation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931476

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026