Cleared Traditional

K122735 - SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2

K122735 is an FDA 510(k) clearance for SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGA..., manufactured by Sorin Group USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K122735 · Sorin Group USA, Inc. · General & Plastic Surgery device
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May 2013
Decision
257d
Days
Class 2
Risk

K122735 is an FDA 510(k) clearance for the SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Sorin Group USA, Inc. (Arvada, US). The FDA issued a Cleared decision on May 21, 2013 after a review of 257 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Sorin Group USA, Inc. devices

FDA 510(k) Submission Details - K122735

510(k) Number K122735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2012
Decision Date May 21, 2013
Days to Decision 257 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
142d slower than avg
Panel avg: 115d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 119
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