Cleared Special

Bearing nsPVA Express?

K233813 · Merit Medical Systems, Inc. · Obstetrics & Gynecology
Dec 2023
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K233813 is an FDA 510(k) clearance for the Bearing nsPVA Express?, a Agents, Embolic, For Treatment Of Uterine Fibroids (Class II — Special Controls, product code NAJ), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 21, 2023, 21 days after receiving the submission on November 30, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K233813 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2023
Decision Date December 21, 2023
Days to Decision 21 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code NAJ — Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

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