K131206 is an FDA 510(k) clearance for the COOK CERVICAL RIPENING BALLOON. This device is classified as a Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor (Class II - Special Controls, product code PFJ).
Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 27, 2013, 151 days after receiving the submission on April 29, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4260. Mechanical Dilation Of The Cervical Canal For Labor..
| 510(k) Number | K131206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2013 |
| Decision Date | September 27, 2013 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PFJ — Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4260 |
| Definition | Mechanical Dilation Of The Cervical Canal For Labor. |