Cleared Traditional

K180533 - Procellera Composite Antibacterial Woun...

K180533 · Vomaris Wound Care, Inc. · General & Plastic Surgery device
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Dec 2018
Decision
285d
Days
-
Risk

K180533 is an FDA 510(k) clearance for the Procellera Composite Antibacterial Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Vomaris Wound Care, Inc. (Tempe, US). The FDA issued a Cleared decision on December 10, 2018 after a review of 285 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 Vomaris Wound Care, Inc. devices

Submission Details

510(k) Number K180533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2018
Decision Date December 10, 2018
Days to Decision 285 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
170d slower than avg
Panel avg: 115d · This submission: 285d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 213
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