Cleared Traditional

K191252 - Gem FlowCoupler System

K191252 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 61-day FDA review.

K191252 · Baxter/ Synovis Micro Companies Alliance, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
61d
Days
Class 2
Risk

K191252 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 July 9, 2019 after a review of 61 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter/ Synovis Micro Companies Alliance, Inc. devices

FDA 510(k) Submission Details - K191252

510(k) Number K191252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2019
Decision Date July 09, 2019
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
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 K191252.
Gem FlowCoupler System
K190499 · Baxter/ Synovis Micro Companies Alliance, Inc. · Sep 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