Cleared Traditional

K232796 - LUOFUCON® Collagen Particles (Collagen Wound Dressing) (FDA 510(k) Clearance)

K232796 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device

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Apr 2024

Decision

226d

Days

Risk

K232796 is an FDA 510(k) clearance for the LUOFUCON® Collagen Particles (Collagen Wound Dressing). Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on April 25, 2024 after a review of 226 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

Submission Details

510(k) Number	K232796 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 12, 2023
Decision Date	April 25, 2024
Days to Decision	226 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