Cleared Traditional

K210098 - PuraStat-GI (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K210098 · 3-D Matrix, Inc. · General & Plastic Surgery device
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Jun 2021
Decision
162d
Days
Class 2
Risk

K210098 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 June 25, 2021 after a review of 162 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 K210098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2021
Decision Date June 25, 2021
Days to Decision 162 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
48d slower than avg
Panel avg: 114d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

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.

Clinical Evidence

ClinicalTrials.gov
NCT02833558 Completed Interventional

Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection

Randomised Controlled Trial Comparing Purastat® to Standard Therapy for Haemostasis Control During Endoscopic Submucosal Dissection

101
Patients (actual)
1
Site
Treatment
Purpose
Single blind
Masking
Condition studied Gastrointestinal Haemorrhage
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Pradeep Bhandari, MBBS, MD
Sponsor Portsmouth Hospitals NHS Trust
Started 2016-05-04 → Primary completion 2018-04-12 → Completed 2018-05-18
Primary outcome
The number of times intraprocedural heat therapy is used to achieve haemostasis in ESD in both the PuraStat® and control arms of the study
Secondary outcome
The length of the procedure in the PuraStat® and control arm of the study
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K210098.
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
Nexpowder
K202929 · Nextbiomedical Co., Ltd. · Sep 2022