FDA 510(k) Obstetrics & Gynecology Devices
About Obstetrics & Gynecology Devices
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
FDA 510(k) Cleared Obstetrics & Gynecology Devices
This page lists all 43 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.
- 43 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 175 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 43 medical devices in the Obstetrics & Gynecology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 43 were cleared as substantially equivalent to a predicate device. Average FDA review time: 175 days. Records from 2021 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to obstetrics & gynecology
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
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.
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices