Cleared Traditional

K222481 - PuraStat (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222481 · 3-D Matrix, Inc. · General & Plastic Surgery device
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Feb 2023
Decision
195d
Days
Class 2
Risk

K222481 is an FDA 510(k) clearance for the PuraStat. 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 February 28, 2023 after a review of 195 days - an extended review 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: 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 K222481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2022
Decision Date February 28, 2023
Days to Decision 195 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 114d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (QAU) and FDA review panel - the closest regulatory comparables to K222481.
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
Nexpowder
K202929 · Nextbiomedical Co., Ltd. · Sep 2022
PuraStat-GI
K210098 · 3-D Matrix, Inc. · Jun 2021