Cleared Traditional

K190499 - Gem FlowCoupler System

K190499 is an FDA 510(k) clearance for Gem FlowCoupler System, manufactured by Baxter/ Synovis Micro Companies Alliance, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MVR cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K190499 · Baxter/ Synovis Micro Companies Alliance, Inc. · General & Plastic Surgery device
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Sep 2019
Decision
189d
Days
Class 2
Risk

K190499 is an FDA 510(k) clearance for the Gem FlowCoupler System. Classified as Device, Anastomotic, Microvascular (product code MVR), Class II - Special Controls.

Submitted by Baxter/ Synovis Micro Companies Alliance, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 6, 2019 after a review of 189 days - an extended review 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. 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 Baxter/ Synovis Micro Companies Alliance, Inc. devices

FDA 510(k) Submission Details - K190499

510(k) Number K190499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2019
Decision Date September 06, 2019
Days to Decision 189 days
Submission Type Traditional
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
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Devices cleared under the same product code (MVR) and FDA review panel - the closest regulatory comparables to K190499.
Gem FlowCoupler System
K191252 · Baxter/ Synovis Micro Companies Alliance, Inc. · Jul 2019
GEM Flow COUPLER Device and System
K143589 · Synovis Life Technologies, Inc. · Jan 2015
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
3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)
K861985 · 3M Company · Dec 1986