Novy Cornual Cannulation Set
FDA 510(k) K931476 · Cook Ob/Gyn
510(k) numberK931476
Submission
- Device name
- Novy Cornual Cannulation Set
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- March 24, 1993
- Decision date
- July 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MOV – Catheters, Salpingography
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MOV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180552 | Modified Novy Cornual Cannulation SetMOV · Special | Cook Incorporated | 07/12/2018SE |
| K932436 | Echomark Intrauterine Guiding CatheterMOV · Traditional | Echocath, Inc. | 11/16/1995SE |
| K953314 | Conceptus Fallopian Tube Catheterization SystemMOV · Traditional | Conceptus, Inc. | 07/28/1995SE |
| K931534 | Ovamed Intrauterine Access CatheterMOV · Traditional | Ovamed Corp. | 07/28/1995SE |
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Questions and answers
When was Novy Cornual Cannulation Set cleared by the FDA?
Novy Cornual Cannulation Set (K931476) received a 510(k) decision of Substantially Equivalent on July 28, 1995, 856 days after the submission was received.
What is the product code of K931476?
The FDA product code is MOV – Catheters, Salpingography, a Class II (moderate risk) device regulated under 21 CFR 884.4530.