K212757 is an FDA 510(k) clearance for the Jada System. This device is classified as a Intrauterine Tamponade Balloon (Class II - Special Controls, product code OQY).
Submitted by Alydia Health (Menlo Park, US). The FDA issued a Cleared decision on September 30, 2021, 30 days after receiving the submission on August 31, 2021.
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 | K212757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2021 |
| Decision Date | September 30, 2021 |
| 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 |