Cleared Traditional

K192346 - scaffolene CL100 Bioresorbable Collagen...

K192346 · Freudenberg Technology Innovation SE & Co. KG · General & Plastic Surgery device
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Feb 2020
Decision
183d
Days
-
Risk

K192346 is an FDA 510(k) clearance for the scaffolene CL100 Bioresorbable Collagen Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Freudenberg Technology Innovation SE & Co. KG (Weinheim, DE). The FDA issued a Cleared decision on February 28, 2020 after a review of 183 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 Freudenberg Technology Innovation SE & Co. KG devices

Submission Details

510(k) Number K192346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2019
Decision Date February 28, 2020
Days to Decision 183 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
68d slower than avg
Panel avg: 115d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Consultant

Parexel International
Sugato De

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 84
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