Cleared Traditional

K171041 - SilverSeal

K171041 · Alliqua Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
137d
Days
-
Risk

K171041 is an FDA 510(k) clearance for the SilverSeal. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Alliqua Biomedical, Inc. (Langhorne, US). The FDA issued a Cleared decision on August 22, 2017 after a review of 137 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.

FDA 510(k) Submission Details - K171041

510(k) Number K171041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2017
Decision Date August 22, 2017
Days to Decision 137 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 115d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K171041.
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
K172486 · Anexa Biomedical, Inc. · Sep 2017
Hexagen Derm
K171191 · Global Health Solutions, LLC · Aug 2017
NEOCERA Advanced Barrier Cream
K170911 · Exeltis USA Dermatology, LLC · Aug 2017
Sorbact Wound Dressing-Ribbon Gauze
K171225 · Abigo Medical AB · Aug 2017
Hydrocleanse Antimicrobial Skin and Wound Care Solution
K171727 · Sonoma Pharmaceuticals · Jul 2017
PHMB Antimicrobial Foam Wound Dressing
K163062 · Advanced Medical Solutions, Ltd. · Jul 2017