Last synced on 20 January 2023 at 11:05 pm

Prosthesis, Fallopian Tube

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.3650
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.3650 Fallopian tube prosthesis

§ 884.3650 Fallopian tube prosthesis.

(a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.

(b) Classification. Class II (performance standards).

Prosthesis, Fallopian Tube

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.3650
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.3650 Fallopian tube prosthesis

§ 884.3650 Fallopian tube prosthesis.

(a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.

(b) Classification. Class II (performance standards).