Cleared Traditional

K242250 - PuraStat (FDA 510(k) Clearance)

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

K242250 · 3-D Matrix Europe SAS · General & Plastic Surgery device
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Oct 2024
Decision
83d
Days
Class 2
Risk

K242250 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 Europe SAS (Caluire Et Cuire, FR). The FDA issued a Cleared decision on October 22, 2024 after a review of 83 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 Europe SAS devices

Submission Details

510(k) Number K242250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2024
Decision Date October 22, 2024
Days to Decision 83 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
31d faster than avg
Panel avg: 114d · This submission: 83d
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 K242250.
PuraStat
K253924 · 3-D Matrix Europe SAS · Jan 2026
Nexpowder
K240994 · Nextbiomedical Co., Ltd. · Nov 2024
Resolv Endoscopic Hemostat System
K234131 · Hemostasis, LLC · Jul 2024
PuraStat
K222481 · 3-D Matrix, Inc. · Feb 2023
Nexpowder
K202929 · Nextbiomedical Co., Ltd. · Sep 2022
PuraStat-GI
K210098 · 3-D Matrix, Inc. · Jun 2021