QAU · Hemostatic Device For Endoscopic Gastrointestinal Use
General, Plastic Surgery · 21 CFR 878.4456 · Class 2
Overview
| Product Code | QAU |
|---|---|
| Device Name | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Regulation | 21 CFR 878.4456 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
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.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253924 | PuraStat | 3-D Matrix Europe SAS | Jan 7, 2026 | SESE |
| K240994 | Nexpowder | Nextbiomedical Co., Ltd. | Nov 27, 2024 | SESE |
| K242250 | PuraStat | 3-D Matrix Europe SAS | Oct 22, 2024 | SESE |
| K234131 | Resolv Endoscopic Hemostat System | Hemostasis, LLC | Jul 26, 2024 | SESE |
| K222481 | PuraStat | 3-D Matrix, Inc. | Feb 28, 2023 | SESE |
| K202929 | Nexpowder | Nextbiomedical Co., Ltd. | Sep 16, 2022 | SESE |
| K210098 | PuraStat-GI | 3-D Matrix, Inc. | Jun 25, 2021 | SESE |
| K190677 | EndoClot | Endoclot Plus Co., Ltd. | Jan 29, 2021 | SESE |
| K200972 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | Jun 10, 2020 | SESE |
| DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | May 7, 2018 | DENG |
Top Applicants
- 3-D Matrix Europe SAS — 2 clearances
- 3-D Matrix, Inc. — 2 clearances
- Nextbiomedical Co., Ltd. — 2 clearances
- Wilson-Cook Medical, Inc. — 2 clearances
- Endoclot Plus Co., Ltd. — 1 clearance
