K170622 is an FDA 510(k) clearance for the Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component. This device is classified as a Intrauterine Tamponade Balloon (Class II - Special Controls, product code OQY).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 31, 2017, 30 days after receiving the submission on March 1, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530. Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding.
| 510(k) Number | K170622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2017 |
| Decision Date | March 31, 2017 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | OQY — Intrauterine Tamponade Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding |