PON
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Balloon, Dilation Of Cervical Canal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- FDA definition
- Mechanical dilation and softening of the cervix.
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| Record | Firm | Date |
|---|---|---|
| Aqueduct 200 Cervical Dilation Balloon Catheter (K202433) | Gtimd, LLC | 2021-10-15 |
| Aqueduct 100 Plus Cervical Dilation Balloon Catheter (K202427) | Gtimd, LLC | 2020-11-06 |
| CrossBay Cervical Dilator Catheter System (K190813) | Crossbay Medical | 2019-08-23 |
| Aqueduct 100 Cervical Dilator (K160664) | Gtimd, LLC | 2016-08-01 |
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Every clearance here is in the API, with alerts when new ones post.