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:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 167d |
| All-time average (cleared) | 160d |
| Not Substantially Equivalent (denied) | 294d |
FDA review times for Obstetrics & Gynecology submissions have remained consistent, averaging 167 days for cleared devices. Denied submissions averaged 294 days before receiving a Not Substantially Equivalent determination.
This page lists all 4525 medical devices in the Obstetrics & Gynecology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Fetal monitors, breast pumps, IUDs and gynecological surgical instruments.
This page lists 4525 medical devices in the Obstetrics & Gynecology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 4511 were cleared as substantially equivalent to a predicate device. Average FDA review time: 160 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
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