Cleared Traditional

K093310 - GEM FLOW COUPLER DEVICE AND SYSTEM (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
12d faster than avg
Panel avg: 114d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.