Cleared Traditional

K261504 - PuraStat-RM

K261504 · 3-D Matrix, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
89d
Days
-
Risk

K261504 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 August 3, 2026 after a review of 89 days - a notably fast clearance cycle.

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: 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 3-D Matrix, Inc. devices

FDA 510(k) Submission Details - K261504

510(k) Number K261504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2026
Decision Date August 03, 2026
Days to Decision 89 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
42d faster than avg
Panel avg: 131d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

PHN Device Classification - Class 0,

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