FDA Product Code
FDA Product Code PON — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4260
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | 2021-10-15 | Traditional | PDF ↗ |
| K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | 2020-11-06 | Special | PDF ↗ |
| K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | 2019-08-23 | Traditional | PDF ↗ |
| K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | 2016-08-01 | Abbreviated | PDF ↗ |
Product code PON · Class II · Obstetrics/Gynecology. Data: openFDA.