Cleared Traditional

IWD-Gel™ (K254191) - FDA 510(k) Clearance

K254191 · InnovaCorium, Inc. · General & Plastic Surgery device

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Apr 2026

Decision

105d

Days

Risk

K254191 is an FDA 510(k) clearance for the IWD-Gel™. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by InnovaCorium, Inc. (Gainesville, US). The FDA issued a Cleared decision on April 7, 2026 after a review of 105 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.

View all InnovaCorium, Inc. devices

Submission Details

510(k) Number	K254191 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 23, 2025
Decision Date	April 07, 2026
Days to Decision	105 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

10d faster than avg

Panel avg: 115d · This submission: 105d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

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Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K254191

InnovaCorium, Inc.

Gainesville, FL · US

Marcelo Buzzi

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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