PuraStat

K253924 · 3-D Matrix Europe SAS · QAU · Jan 7, 2026 · General, Plastic Surgery

Device Facts

• Record ID: K253924
• Device Name: PuraStat
• Applicant: 3-D Matrix Europe SAS
• Product Code: QAU · General, Plastic Surgery
• Decision Date: Jan 7, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4456
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.

Device Story

PuraStat is a sterile, synthetic peptide-based hydrogel; supplied in prefilled syringe (2.5% peptide). Used by physicians during endoscopic procedures; delivered to bleeding site via endoscopic catheter. Upon contact with physiological fluids (blood), peptide solution rapidly forms transparent hydrogel matrix; creates physical barrier to block blood flow. Non-animal/non-plant derived; preservative-free. Intended for use in GI tract to manage mild/moderate bleeding; prevents post-procedure bleeding. Benefits include effective hemostasis without volume expansion.

Clinical Evidence

Bench testing only. Validation included Gamma and EtO sterilization (ISO 11137, ISO 11135), packaging validation (ISO 11607), product stability, biocompatibility (ISO 10993-1), EO/ECH residual analysis (ISO 10993-7), and mechanical syringe performance testing.

Technological Characteristics

Synthetic peptide hydrogel (2.5% peptide content) in sterile water. Delivered via endoscopic catheter with polypropylene adapter. Sterilization via Gamma or EtO. Complies with ISO 11137, ISO 11135, ISO 11607, ISO 10993-1, and ISO 10993-7.

Indications for Use

Indicated for hemostasis of mild/moderate bleeding post ESD or EMR, intraprocedural venous bleeding, and primary non-variceal GI bleeding. Contraindicated for arterial Forrest 1a bleeding.

Regulatory Classification

Identification

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.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible. (2) Performance data must support the sterility and pyrogenicity of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following: (i) The ability to deliver the hemostatic material to the bleeding site; (ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and (iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids. (ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems. (6) Labeling must include: (i) Information identifying and explaining how to use the device and its components; and (ii) A shelf life.

Predicate Devices

• PuraStat (3-D Matrix Europe SAS) (K242250)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

January 07, 2026

3-D Matrix Europe SAS
Audrey Vion
Regulatory Affairs & Quality Assurance Manager
11 Chemin Des Petites Brosses
2nd Floor
Caluire Et Cuire, Rhone 69300
France

Re: K253924
Trade/Device Name: PuraStat
Regulation Number: 21 CFR 878.4456
Regulation Name: Hemostatic Device For Intraluminal Gastrointestinal Use
Regulatory Class: Class II
Product Code: QAU
Dated: December 8, 2025
Received: December 8, 2025

Dear Audrey Vion:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K253924 - Audrey Vion
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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K253924 - Audrey Vion
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TEK N. LAMICHHANE -S

Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253924 | |
| Device Name PuraStat | |
| Indications for Use (Describe) PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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510(k) Summary – K253924
Page 1 of 2

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below for this Special 510(k) (K253924).

## 1. SUBMITTER

3-D Matrix Europe SAS
11 chemin des Petites Brosses
69300 Caluire et Cuire - FRANCE

Contact Person: Audrey VION
Phone: [phone]
Email: [e-mail]

Date Prepared: January 06, 2026

## 2. DEVICE

Name of Device: PuraStat
Common Name: Hemostatic device for intraluminal gastrointestinal use
Classification Regulation: 21 CFR 878.4456
Regulatory Class: II
Product Code: QAU
Panel: General & Plastic Surgery

## 3. PREDICATE DEVICE

Predicate Device: PuraStat (3-D Matrix Europe SAS) - K242250

## 4. DEVICE DESCRIPTION

PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter also commercially available.

PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

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510(k) Summary – K253924
Page 2 of 2

# 5. INDICATIONS FOR USE

PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.

# 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The modified PuraStat complies with the special controls for a hemostatic device for intraluminal gastrointestinal internal use as the already cleared PuraStat K242250. The modified PuraStat is identical to already cleared PuraStat K242250 in material, formulation, and manufacturing steps except for the additional sterilization method and minor differences in the packaging and syringe components. Because of these minor changes, it is being submitted as a special 510(k).

# 7. PERFORMANCE DATA

The determination of substantial equivalence is based on an assessment of non-clinical performance data. To verify that the device design modifications meet the functional and performance requirements, PuraStat underwent the following performance testing.

- Gamma Sterilization Validation / ISO 11137
- Product performance
- Packaging Validation / ISO 11607
- Product stability over shelf life
- Biocompatibility / ISO 10993-1

The tests were performed on the subject device using the same methods, and acceptance criteria used for the predicate device

Additional performance testing has been conducted to assess the changes introduced:

- EtO Sterilization Validation / ISO 11135
- EO/ECH residual analysis / ISO 10993-7
- Equivalence in mechanical properties of syringe component by comparing predicate and subject device components.

# 8. CONCLUSION

The subject PuraStat has identical intended use and indications as the predicate PuraStat (K242250).

Technological characteristics between the predicate PuraStat (K242250) and the subject device are identical, with the exception of the final sterilization and minor differences in the packaging and syringe components. These differences do not raise any new questions of safety or effectiveness. PuraStat is identical in materials, formulation, overall manufacturing, and in final product specifications to the predicate PuraStat (K242250).

PuraStat complies with the special controls for a hemostatic device for intraluminal gastrointestinal internal use.

In conclusion, the modified PuraStat is substantially equivalent to the original PuraStat (K242250).