Cleared Traditional

G4Derm / G4Derm Plus Synthetic Wound Matrix (K222025) - FDA 510(k) Clearance

K222025 · Gel4med, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
457d
Days
-
Risk

K222025 is an FDA 510(k) clearance for the G4Derm / G4Derm Plus Synthetic Wound Matrix. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Gel4med, Inc. (Brighton, US). The FDA issued a Cleared decision on October 11, 2023 after a review of 457 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Gel4med, Inc. devices

Submission Details

510(k) Number K222025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2022
Decision Date October 11, 2023
Days to Decision 457 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
Regulatory Context
Review time vs. panel average
342d slower than avg
Panel avg: 115d · This submission: 457d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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