Cleared Traditional

K173544 - Phoenix Wound Matrix

K173544 · Nanofiber Solutions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
106d
Days
-
Risk

K173544 is an FDA 510(k) clearance for the Phoenix Wound Matrix. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Nanofiber Solutions, Inc. (Hilliard, US). The FDA issued a Cleared decision on March 2, 2018 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Nanofiber Solutions, Inc. devices

FDA 510(k) Submission Details - K173544

510(k) Number K173544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2017
Decision Date March 02, 2018
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

QSZ Device Classification - Class 0,

Product Code QSZ Absorbable Synthetic Wound Dressing
Device Class -
Definition Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.

Regulatory Peers - QSZ Absorbable Synthetic Wound Dressing

All 17
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K173544.
SiOxD Wound Matrix
K222189 · Sioxmed, LLC · Nov 2022
NovoSorb Matrix
K221686 · Polynovo Biomaterials Pty, Ltd. · Sep 2022
Restrata®
K193583 · Acera Surgical, Inc. · Sep 2020
NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
K172140 · Polynovo Biomaterials Pty, Ltd. · Aug 2017
SupraSDRM Biodegradable Matrix Wound Dressing
K170213 · Polymedics Innovations, GmbH · Jun 2017
Restrata Wound Matrix
K170300 · Acera Surgical, Inc. · Apr 2017