Cleared Traditional

K213552 - PuraStat-RM (FDA 510(k) Clearance)

K213552 · 3-D Matrix, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
144d
Days
-
Risk

K213552 is an FDA 510(k) clearance for the PuraStat-RM. Classified as Protective Coating, Mucoadhesive Application, For The Rectal Mucosa (product code PHN).

Submitted by 3-D Matrix, Inc. (Newton, US). The FDA issued a Cleared decision on April 1, 2022 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all 3-D Matrix, Inc. devices

Submission Details

510(k) Number K213552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2021
Decision Date April 01, 2022
Days to Decision 144 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 130d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device Class -
Definition Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa.

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.