Cleared Special

K143589 - GEM Flow COUPLER Device and System

K143589 is an FDA 510(k) clearance for GEM Flow COUPLER Device and System, manufactured by Synovis Life Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MVR cleared through the Special 510(k) pathway after a 29-day FDA review.

K143589 · Synovis Life Technologies, Inc. · General & Plastic Surgery device
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Jan 2015
Decision
29d
Days
Class 2
Risk

K143589 is an FDA 510(k) clearance for the GEM Flow COUPLER Device and System. Classified as Device, Anastomotic, Microvascular (product code MVR), Class II - Special Controls.

Submitted by Synovis Life Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synovis Life Technologies, Inc. devices

FDA 510(k) Submission Details - K143589

510(k) Number K143589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date January 16, 2015
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MVR Device Classification - Class 2, Special Controls

Product Code MVR Device, Anastomotic, Microvascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MVR Device, Anastomotic, Microvascular

All 7
Devices cleared under the same product code (MVR) and FDA review panel - the closest regulatory comparables to K143589.
Gem FlowCoupler System
K190499 · Baxter/ Synovis Micro Companies Alliance, Inc. · Sep 2019
Gem FlowCoupler System
K191252 · Baxter/ Synovis Micro Companies Alliance, Inc. · Jul 2019
GEM Flow COUPLER Device and System
K142309 · Synovis Life Technologies, Inc. · Sep 2014
GEM FLOW COUPLER DEVICE AND SYSTEM
K132727 · Synovis Life Technologies, Inc. · Oct 2013
GEM FLOW COUPLER DEVICE AND SYSTEM
K093310 · Synovis Micro Companies Alliance, Inc. · Feb 2010
VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
K090679 · Vioptix, Inc. · Apr 2009