Cleared Traditional

K160022 - LUOFUCON Silicone Ag foam dressing

K160022 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
225d
Days
-
Risk

K160022 is an FDA 510(k) clearance for the LUOFUCON Silicone Ag foam dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on August 17, 2016 after a review of 225 days - an extended review cycle.

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 Huizhou Foryou Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K160022

510(k) Number K160022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2016
Decision Date August 17, 2016
Days to Decision 225 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
110d slower than avg
Panel avg: 115d · This submission: 225d
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 454
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