Cleared Traditional

K232758 - Comatryx OTC (FDA 510(k) Clearance)

K232758 · Strukmyer Medical, LLC · General & Plastic Surgery device
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Dec 2023
Decision
84d
Days
-
Risk

K232758 is an FDA 510(k) clearance for the Comatryx OTC. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Strukmyer Medical, LLC (Mesquite, US). The FDA issued a Cleared decision on December 1, 2023 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Strukmyer Medical, LLC devices

Submission Details

510(k) Number K232758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2023
Decision Date December 01, 2023
Days to Decision 84 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
30d faster than avg
Panel avg: 114d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

Richard Hamer Associates, LLC
Richard Hamer

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)

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