CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR884]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 884 OBSTETRICAL AND GYNECOLOGICAL DEVICES

Subpart D - Obstetrical and Gynecological Prosthetic Devices

Sec. 884.3200 Cervical drain.

(a) Identification. A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]

Sec. 884.3575 Vaginal pessary.

(a) Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.

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

Sec. 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).

Sec. 884.3900 Vaginal stent.

(a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.

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

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l , 371.
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.