FDA 21 CFR Part 884 Obstetrical and Gynecological Devices

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Table of contents

Subpart A - General Provisions

884.1 Scope.

884.3 Effective dates of requirement for premarket approval.

884.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B - Obstetrical and Gynecological Diagnostic Devices

884.1040 Viscometer for cervical mucus.

884.1050 Endocervical aspirator.

884.1060 Endometrial aspirator.

884.1100 Endometrial brush.

884.1175 Endometrial suction curette and accessories.

884.1185 Endometrial washer.

884.1300 Uterotubal carbon dioxide insufflator and accessories.

884.1425 Perineometer.

884.1550 Amniotic fluid sampler (amniocentesis tray).

884.1560 Fetal blood sampler.

884.1600 Transabdominal amnioscope (fetoscope) and accessories.

884.1630 Colposcope.

884.1640 Culdoscope and accessories.

884.1660 Transcervical endoscope (amnioscope) and accessories.

884.1690 Hysteroscope and accessories.

884.1700 Hysteroscopic insufflator.

884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.

884.1720 Gynecologic laparoscope and accessories.

884.1730 Laparoscopic insufflator.

Subpart C - Obstetrical and Gynecological Monitoring Devices

Subpart D - Obstetrical and Gynecological Prosthetic Devices

Subpart E - Obstetrical and Gynecological Surgical Devices

Subpart F - Obstetrical and Gynecological Therapeutic Devices, (and)

Subpart G - Assisted Reproduction Devices

FDA 21 CFR Part 884 Obstetrical and Gynecological Devices: