Cleared Traditional

K152544 - Agem Ag Mesh Dressing with Silver

K152544 · Shenzhen Yuanxing Nano-Pharma Co., Ltd. · General & Plastic Surgery device
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May 2016
Decision
262d
Days
-
Risk

K152544 is an FDA 510(k) clearance for the Agem Ag Mesh Dressing with Silver. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Shenzhen Yuanxing Nano-Pharma Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 23, 2016 after a review of 262 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 Shenzhen Yuanxing Nano-Pharma Co., Ltd. devices

FDA 510(k) Submission Details - K152544

510(k) Number K152544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2015
Decision Date May 23, 2016
Days to Decision 262 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 115d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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