Cleared Traditional

K093310 - GEM FLOW COUPLER DEVICE AND SYSTEM

K093310 is an FDA 510(k) clearance for GEM FLOW COUPLER DEVICE AND SYSTEM, manufactured by 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 102-day FDA review.

K093310 · Synovis Micro Companies Alliance, Inc. · General & Plastic Surgery device
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Feb 2010
Decision
102d
Days
Class 2
Risk

K093310 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 Micro Companies Alliance, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 1, 2010 after a review of 102 days - within the typical 510(k) review window.

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 Synovis Micro Companies Alliance, Inc. devices

FDA 510(k) Submission Details - K093310

510(k) Number K093310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2009
Decision Date February 01, 2010
Days to Decision 102 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
13d faster than avg
Panel avg: 115d · This submission: 102d
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.