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PuraStat Hemostatic Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242250

by 3-D Matrix Europe SAS

Identifiers

510(k) Number
K242250 FDA 510(k)
FDA Product Code
QAU FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4456 FDA 510(k)
Regulation Number
878.4456 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

PuraStat is a synthetic hemostatic material classified as a Hemostatic Device for Endoscopic Gastrointestinal Use. It is designed to control mild to moderate bleeding during endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR), serving as an adjunctive, bridge, prophylactic, or rescue therapy for intraprocedural venous bleeding or to prevent post-procedure hemorrhage in gastrointestinal procedures.

Supplied as a prefilled syringe, PuraStat is intended for single-use applications in endoscopic settings. The device is regulated under 21 CFR 878.4456 and holds a Traditional 510(k) clearance from the FDA, classified as a Class II medical device. It is not sterilized for reuse and must be stored according to manufacturer instructions to maintain efficacy.

Frequently asked questions

What is PuraStat designed to do during endoscopic procedures?

PuraStat is a synthetic hemostatic material specifically engineered to control mild to moderate bleeding during endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR). It serves as an adjunctive, bridge, prophylactic, or rescue therapy to address intraprocedural venous bleeding or to prevent post-procedure hemorrhage in gastrointestinal procedures.

How is PuraStat supplied and intended for use?

PuraStat is supplied as a prefilled syringe, making it ready for immediate use in endoscopic settings. It is designed exclusively for single-use applications, ensuring sterility and efficacy for one procedure only. This design eliminates the need for reprocessing or sterilization between uses.

Is PuraStat reusable or must it be discarded after use?

PuraStat is strictly intended for single-use only. It is not sterilized for reuse, and reprocessing or reusing the device could compromise its performance and safety. Always adhere to the manufacturer’s instructions for storage and disposal to maintain efficacy and compliance.

What regulatory classification and clearance does PuraStat hold?

PuraStat is classified as a Class II medical device under 21 CFR 878.4456 and holds a Traditional 510(k) clearance from the FDA. This classification and clearance confirm its substantial equivalence to a predicate device, ensuring it meets established safety and performance standards for hemostatic materials used in endoscopic gastrointestinal procedures.

How should PuraStat be stored to ensure it remains effective?

PuraStat must be stored according to the manufacturer’s instructions to preserve its sterility and efficacy. Proper storage conditions typically include protection from extreme temperatures, moisture, and contamination. Always check the packaging for specific storage guidelines before use to ensure optimal performance during endoscopic procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PuraStat - 3-D Matrix, PuraStat - Product Overview - 3-D Matrix, PDF MEDICAL TECHNOLOGY PuraStat Clear haemostatic control, PDF October 22, 2024 3-D Matrix Europe SAS Audrey Vion RAQA Manager Caluire ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
3-D Matrix Europe SAS

Sources (1)

  • FDA 510(k) K242250 24 fields · synced Oct 1, 2026