Cleared Traditional

ReyaGel (RG03 - MTP gel 3mL) (K232204) - FDA 510(k) Clearance

K232204 · Fettech · General & Plastic Surgery device
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Apr 2024
Decision
269d
Days
-
Risk

K232204 is an FDA 510(k) clearance for the ReyaGel (RG03 - MTP gel 3mL). Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Fettech (Sunrise, US). The FDA issued a Cleared decision on April 19, 2024 after a review of 269 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.

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Submission Details

510(k) Number K232204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2023
Decision Date April 19, 2024
Days to Decision 269 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
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 73
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K232204.
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K241706 · Acell, Inc. · Jul 2024
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K241724 · Acell, Inc. · Jul 2024
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K232796 · Huizhou Foryou Medical Devices Co., Ltd. · Apr 2024
Miro3D Fibers Wound Matrix
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MiroDry Wound Matrix
K240277 · Reprise Biomedical, Inc. · Mar 2024
Corplex P / Theracor P / Allacor P
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