Catheters, Salpingography
Salpingography Catheters are obstetrics/gynecology devices used to cannulate and inject contrast medium into the fallopian tubes for imaging purposes (salpingography), enabling evaluation of tubal patency in the workup of female infertility. Classified as FDA Class 2 under 21 CFR 884.4530, they require 510(k) premarket notification. The product code is MOV, and they are eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MOV
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K180552 | Modified Novy Cornual Cannulation Set | Jul 12, 2018 | Substantially Equivalent | Cook Incorporated |
| K932436 | ECHOMARK INTRAUTERINE GUIDING CATHETER | Nov 16, 1995 | Substantially Equivalent | Echocath, Inc. |
| K953314 | CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM | Jul 28, 1995 | Substantially Equivalent | Conceptus, Inc. |
| K931534 | OVAMED INTRAUTERINE ACCESS CATHETER | Jul 28, 1995 | Substantially Equivalent | Ovamed Corp. |
| K931476 | NOVY CORNUAL CANNULATION SET | Jul 28, 1995 | Substantially Equivalent | Cook Ob/Gyn |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.