Cleared Special

Jada System

K212757 · Alydia Health · Obstetrics & Gynecology

Sep 2021

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K212757 is an FDA 510(k) clearance for the Jada System, 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 review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K212757 FDA.gov
FDA Decision	Cleared 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

Device Classification

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