K190813 is an FDA 510(k) clearance for the CrossBay Cervical Dilator Catheter System. This device is classified as a Catheter, Balloon, Dilation Of Cervical Canal (Class II - Special Controls, product code PON).
Submitted by Crossbay Medical (San Diego, US). The FDA issued a Cleared decision on August 23, 2019, 147 days after receiving the submission on March 29, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4260. Mechanical Dilation And Softening Of The Cervix..
| 510(k) Number | K190813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2019 |
| Decision Date | August 23, 2019 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PON — Catheter, Balloon, Dilation Of Cervical Canal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4260 |
| Definition | Mechanical Dilation And Softening Of The Cervix. |