Cleared Traditional

Kerecis Silicone (K213231) - FDA 510(k) Clearance

K213231 · Kerecis Limited · General & Plastic Surgery device
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Jun 2022
Decision
272d
Days
-
Risk

K213231 is an FDA 510(k) clearance for the Kerecis Silicone. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on June 29, 2022 after a review of 272 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 Kerecis Limited devices

Submission Details

510(k) Number K213231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date June 29, 2022
Days to Decision 272 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
157d slower than avg
Panel avg: 115d · This submission: 272d
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 K213231.
Foundation Dermal Regeneration Scaffold (DRS) Solo
K210949 · Bionova Medical, Inc. · Aug 2022
PELNAC Meshed Bilayer Wound Matrix
K213498 · Gunze Limited · Jul 2022
PuraPly Micronized Wound Matrix (PuraPly MZ)
K220317 · Organogenesis, Inc. · Jul 2022
Fibrillar Collagen Wound Dressing
K213341 · Collagen Matrix, Inc. · May 2022
Geistlich Wound Matrix PLUS
K213607 · Geistlich Pharma AG · Apr 2022
PELNAC Wound Matrix
K213573 · Gunze Limited · Feb 2022