Cleared Traditional

K153746 - Dunamis Force DFX Tensile Tape

K153746 is an FDA 510(k) clearance for Dunamis Force DFX Tensile Tape, manufactured by Dunamis, LLC. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K153746 · Dunamis, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
65d
Days
Class 2
Risk

K153746 is an FDA 510(k) clearance for the Dunamis Force DFX Tensile Tape. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Dunamis, LLC (Greenville, US). The FDA issued a Cleared decision on March 3, 2016 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dunamis, LLC devices

FDA 510(k) Submission Details - K153746

510(k) Number K153746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2015
Decision Date March 03, 2016
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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

Compliance Systems International, LLC
Robert O Dean

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 141
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K153746.
'cottony' II TAPE, PLEDGETS
K153089 · Teleflexmedical, Inc. · Aug 2016
IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
K153087 · Ivy Sports Medicine, LLC · Jul 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
ExpressBraid Graft Manipulation
K152868 · Biomet Manufacturing Corp · Feb 2016
LARIAT RS Suture Delivery Device
K153096 · Sentreheart, Inc. · Nov 2015