Cleared Traditional

PuraDERM Gel (K193085) - FDA 510(k) Clearance

K193085 · 3-D Matrix, Inc. · General & Plastic Surgery device
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May 2020
Decision
188d
Days
-
Risk

K193085 is an FDA 510(k) clearance for the PuraDERM Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3-D Matrix, Inc. (Needham, US). The FDA issued a Cleared decision on May 11, 2020 after a review of 188 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 3-D Matrix, Inc. devices

Submission Details

510(k) Number K193085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2019
Decision Date May 11, 2020
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Streamline Regulatory
Stephen P. Rhodes

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 - FRO Dressing, Wound, Drug

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