Cleared Traditional

K130259 - BEARING NSPVA EMBOLIZATION PARTICLES

K130259 is the FDA 510(k) clearance for BEARING NSPVA EMBOLIZATION PARTICLES by Merit Medical Systems, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code NAJ) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K130259 · Merit Medical Systems, Inc. · Obstetrics & Gynecology device
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Jun 2013
Decision
126d
Days
Class 2
Risk

K130259 is an FDA 510(k) clearance for the BEARING NSPVA EMBOLIZATION PARTICLES. Classified as Agents, Embolic, For Treatment Of Uterine Fibroids (product code NAJ), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Rockland, US). The FDA issued a Cleared decision on June 7, 2013 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 870.3300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K130259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2013
Decision Date June 07, 2013
Days to Decision 126 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 160d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - NAJ Agents, Embolic, For Treatment Of Uterine Fibroids

Devices cleared under the same product code (NAJ) and FDA review panel - the closest regulatory comparables to K130259.
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