Cleared Traditional

K261503 - PuraStat GI

K261503 is an FDA 510(k) clearance for PuraStat GI, manufactured by 3-D Matrix, Inc.. The device is a Class 2 General & Plastic Surgery device with product code QAU cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K261503 · 3-D Matrix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
89d
Days
Class 2
Risk

K261503 is an FDA 510(k) clearance for the PuraStat GI. Classified as Hemostatic Device For Endoscopic Gastrointestinal Use (product code QAU), Class II - Special Controls.

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 General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4456 - the FDA general and plastic surgery device framework. 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 - K261503

510(k) Number K261503 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 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QAU Device Classification - Class 2, Special Controls

Product Code QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4456
Definition Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QAU Hemostatic Device For Endoscopic Gastrointestinal Use

All 11
Devices cleared under the same product code (QAU) and FDA review panel - the closest regulatory comparables to K261503.
Hemospray Endoscopic Hemostat (HEMO-[X])
K253302 · Wilson-Cook Medical, Inc. · Jun 2026
PuraStat
K253924 · 3-D Matrix Europe SAS · Jan 2026
Nexpowder
K240994 · Nextbiomedical Co., Ltd. · Nov 2024
PuraStat
K242250 · 3-D Matrix Europe SAS · Oct 2024
Resolv Endoscopic Hemostat System
K234131 · Hemostasis, LLC · Jul 2024
PuraStat
K222481 · 3-D Matrix, Inc. · Feb 2023