FDA 510(k) Obstetrics & Gynecology Devices

FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview

FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.

Key categories:

• Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
• Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
• Breast pumps and lactation aids - electric and manual breast pumps
• Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
• Pregnancy test systems - hCG detection devices for professional and home use