Panels › Obstetrics/Gynecology › Product code PON · Class 2
Catheter, Balloon, Dilation Of Cervical Canal
Regulation 884.4260
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PON
| Company | 510(k)s | Recalls |
|---|---|---|
| Gtimd, LLC | 3 | 0 |
| Crossbay Medical | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2021 | K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter Gtimd, LLC | PON |
| Nov 6, 2020 | K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter Gtimd, LLC | PON |
| Aug 23, 2019 | K190813 | CrossBay Cervical Dilator Catheter System Crossbay Medical | PON |
| Aug 1, 2016 | K160664 | Aqueduct 100 Cervical Dilator Gtimd, LLC | PON |
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