Product Code: MOV FDA class 2 21 CFR 884.4530

Catheters, Salpingography

Obstetrics/Gynecology

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.

510(k)s
5
FEI Numbers
3
Registration Numbers
3
Unique Applicants
5
Years Active
23

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 5 510(k) clearances via K numbers.

K Number Device Name
K180552 Modified Novy Cornual Cannulation Set
K932436 ECHOMARK INTRAUTERINE GUIDING CATHETER
K953314 CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM
K931534 OVAMED INTRAUTERINE ACCESS CATHETER
K931476 NOVY CORNUAL CANNULATION SET

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.