Cleared Traditional

K131659 - MOERAE VEIN PREPARATION KIT

K131659 is an FDA 510(k) clearance for MOERAE VEIN PREPARATION KIT, manufactured by Moerae Matrix, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 270-day FDA review.

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

FDA 510(k) Submission Details - K131659

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.

GBX Device Classification - Class 1, General Controls

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 41
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K131659.
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703 · Allegiance Healthcare Corp. · Dec 1997
ULTRACELL SUCTION SPONGE
K972635 · Ultracell Medical Technologies, Inc. · Oct 1997
FLAT CLOSED WOUND DRAIN WITH TROCAR
K965146 · Axiom Medical, Inc. · Mar 1997
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
K961295 · Sil-Med Corp. · Jun 1996
CLOSED FLUID COLLECTION SYSTEM
K961147 · B.Braun Medical, Inc. · May 1996
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
K960955 · Baxter Healthcare Corp · May 1996