PON — Catheter, Balloon, Dilation Of Cervical Canal Class II
FDA product code PON covers "Catheter, Balloon, Dilation Of Cervical Canal", a Class II medical device regulated under 21 CFR 884.4260. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PON
- Device Class
- Class II
- Regulation Number
- 884.4260
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
Mechanical dilation and softening of the cervix.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202433 | gtimd | Aqueduct 200 Cervical Dilation Balloon Catheter | October 15, 2021 |
| K202427 | gtimd | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | November 6, 2020 |
| K190813 | crossbay medical | CrossBay Cervical Dilator Catheter System | August 23, 2019 |
| K160664 | gtimd | Aqueduct 100 Cervical Dilator | August 1, 2016 |