Cleared Traditional

MESH GPS - LARGE, SMALL, SM, SM SMALL (K092726) - FDA 510(k) Clearance

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

K092726 · Surgical Structures , Ltd. · General & Plastic Surgery device
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Mar 2010
Decision
193d
Days
Class 2
Risk

K092726 is an FDA 510(k) clearance for the MESH GPS - LARGE, SMALL, SM, SM SMALL. Classified as Mesh, Surgical, Deployment Balloon (product code OQL), Class II - Special Controls.

Submitted by Surgical Structures , Ltd. (Chalotte, US). The FDA issued a Cleared decision on March 15, 2010 after a review of 193 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 Surgical Structures , Ltd. devices

Submission Details

510(k) Number K092726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2009
Decision Date March 15, 2010
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OQL Mesh, Surgical, Deployment Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition The Device Is Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Hernias.
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.