Cleared Traditional

K161638 - SPEEDTRAP Graft Preparation System

K161638 is an FDA 510(k) clearance for SPEEDTRAP Graft Preparation System, manufactured by Medos International SARL. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K161638 · Medos International SARL · General & Plastic Surgery device
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Nov 2016
Decision
146d
Days
Class 2
Risk

K161638 is an FDA 510(k) clearance for the SPEEDTRAP Graft Preparation System. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on November 7, 2016 after a review of 146 days - within the typical 510(k) review window.

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 Medos International SARL devices

FDA 510(k) Submission Details - K161638

510(k) Number K161638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2016
Decision Date November 07, 2016
Days to Decision 146 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
31d slower than avg
Panel avg: 115d · This submission: 146d
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 Consultant

Depuy Mitek, A Johnson and Johnson Company
Jeffrey Dzialo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 113
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K161638.
SpeedStitch Suture Passer
K163142 · ArthroCare Corporation · Jan 2017
PERMATAPE
K162247 · Medos International SARL · Dec 2016
XBraid TT Suture Tape
K162310 · Stryker · Nov 2016
'cottony' II TAPE, PLEDGETS
K153089 · Teleflexmedical, Inc. · Aug 2016
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
K153076 · Teleflexmedical, Inc. · Jun 2016
HS SutureTape
K153307 · Riverpoint Medical · Feb 2016