Cleared Traditional

K221218 - Silverlon Wound Contact, Burn Contact Dressings (FDA 510(k) Clearance)

K221218 · Argentum Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
182d
Days
-
Risk

K221218 is an FDA 510(k) clearance for the Silverlon Wound Contact, Burn Contact Dressings. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum Medical, Inc. (Geneva, US). The FDA issued a Cleared decision on October 26, 2022 after a review of 182 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 Argentum Medical, Inc. devices

Submission Details

510(k) Number K221218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2022
Decision Date October 26, 2022
Days to Decision 182 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
68d slower than avg
Panel avg: 114d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Clinical Evidence

ClinicalTrials.gov
NCT04238728 Completed Interventional

Silverlon to Reduce Radiation Dermatitis

An Unblinded, Open-label Study Evaluating the Safety of Silverlon to Manage Radiation Dermatitis.

31
Patients (actual)
1
Site
Supportive_care
Purpose
Open label
Masking
Condition studied Radiation Dermatitis
Study design Single group
Eligibility Female only · 22 Years+
Sponsor University of Rochester
Started 2020-08-31 → Primary completion 2022-03-01 → Completed 2022-03-25
Primary outcome
Number of Participants With an Adverse Skin Event
Secondary outcome
Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score
View full study on ClinicalTrials.gov

Regulatory Peers - FRO Dressing, Wound, Drug

All 700
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K221218.
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