Obstetrics/Gynecology FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance in Obstetrics/Gynecology from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
10 clearances in the last 90 days. The same 90 days a year earlier: 6.
For contract manufacturers and test labs
Obstetrics/Gynecology accounts for 10 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is NUC (Lubricant, Personal). Contract manufacturers and test labs that work on Obstetrics/Gynecology devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
NUC | Lubricant, Personal | 2 |
HGM | System, Monitoring, Perinatal | 1 |
HGX | Pump, Breast, Powered | 1 |
HIH | Hysteroscope (And Accessories) | 1 |
KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 29, 2026 | TZ Medical | TZ Medical Birthing Balloon Kit | K262570 |
| Oct 16, 2026 | Tomy International, Inc. | MODO DUO Electric Pump (B11621, B11673) | K261782 |
| Oct 9, 2026 | Allwin Medical Devices, Inc. | The D-Tip Denudation Pipette | K261234 |
| Sep 24, 2026 | Karl Storz SE & CO. KG | KARL STORZ SUPRALOOP | K254303 |
| Sep 23, 2026 | Special Situations, LLC | Everslide | K260117 |
| Sep 3, 2026 | Marani Health, Inc. | Mcare System (MW-20) | K253673 |
| Aug 19, 2026 | CooperSurgical, Inc. | Wallace Aspiration Pump (WAPV1); Wallace Pump Filter Connector (WFC); Wallace Vacuum Connection Kit (WVCK) | K261083 |
| Aug 18, 2026 | Axora Medical, Inc. | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | K260984 |
| Aug 10, 2026 | Datex Ohmeda, Inc. | Novii+ Wireless Patch System | K254036 |
| Aug 7, 2026 | Bumlicious, LLC (DBA Bumlicious) | BUM Oil | K261905 |
- Oct 29, 2026TZ Medical
TZ Medical Birthing Balloon Kit
- Oct 16, 2026Tomy International, Inc.
MODO DUO Electric Pump (B11621, B11673)
- Oct 9, 2026Allwin Medical Devices, Inc.
The D-Tip Denudation Pipette
- Sep 24, 2026Karl Storz SE & CO. KG
KARL STORZ SUPRALOOP
- Sep 23, 2026Special Situations, LLC
Everslide
- Sep 3, 2026Marani Health, Inc.
Mcare System (MW-20)
- Aug 19, 2026CooperSurgical, Inc.
Wallace Aspiration Pump (WAPV1); Wallace Pump Filter Connector (WFC); Wallace Vacuum Connection Kit (WVCK)
- Aug 18, 2026Axora Medical, Inc.
HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
- Aug 10, 2026Datex Ohmeda, Inc.
Novii+ Wireless Patch System
- Aug 7, 2026Bumlicious, LLC (DBA Bumlicious)
BUM Oil
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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