Cleared Special

K153307 - HS SutureTape

K153307 is an FDA 510(k) clearance for HS SutureTape, manufactured by Riverpoint Medical. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Special 510(k) pathway after a 88-day FDA review.

K153307 · Riverpoint Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
88d
Days
Class 2
Risk

K153307 is an FDA 510(k) clearance for the HS SutureTape. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on February 12, 2016 after a review of 88 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Riverpoint Medical devices

FDA 510(k) Submission Details - K153307

510(k) Number K153307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2015
Decision Date February 12, 2016
Days to Decision 88 days
Submission Type Special
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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

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 141
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K153307.
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
Dunamis Force DFX Tensile Tape
K153746 · Dunamis, LLC · Mar 2016
ExpressBraid Graft Manipulation
K152868 · Biomet Manufacturing Corp · Feb 2016
LARIAT RS Suture Delivery Device
K153096 · Sentreheart, Inc. · Nov 2015
ALAR Nasal Valve Stent
K151758 · Medtronic Xomed, Inc. · Oct 2015