Cleared Traditional

MOERAE VEIN PREPARATION KIT (K131659) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K131659 · Moerae Matrix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
270d
Days
Class 1
Risk

K131659 is an FDA 510(k) clearance for the MOERAE VEIN PREPARATION KIT. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Moerae Matrix, Inc. (San Carlos, US). The FDA issued a Cleared decision on March 3, 2014 after a review of 270 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Moerae Matrix, Inc. devices

Submission Details

510(k) Number K131659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2013
Decision Date March 03, 2014
Days to Decision 270 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 115d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBX Catheter, Irrigation

All 76
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K131659.
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
K960955 · Baxter Healthcare Corp · May 1996
VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE
K925176 · Boston Scientific Corp · Apr 1993
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614 · Baxter Healthcare Corp · Mar 1991
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984