PuraStat
FDA 510(k) K222481 · 3-D Matrix, Inc.
510(k) numberK222481
Submission
- Device name
- PuraStat
- Applicant
- 3-D Matrix, Inc.
Newton, MA, US - Received
- August 17, 2022
- Decision date
- February 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAU – Hemostatic Device For Endoscopic Gastrointestinal Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4456
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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.
Other 510(k)s with product code QAU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261503 | PuraStat GIQAU · Traditional | 3-D Matrix, Inc. | 08/03/2026SE |
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X])QAU · Traditional | Wilson-Cook Medical, Inc. | 06/02/2026SE |
| K253924 | PuraStatQAU · Special | 3-D Matrix Europe SAS | 01/07/2026SE |
| K240994 | NexpowderQAU · Traditional | Nextbiomedical Co., Ltd. | 11/27/2024SE |
| K242250 | PuraStatQAU · Traditional | 3-D Matrix Europe SAS | 10/22/2024SE |
| K234131 | Resolv Endoscopic Hemostat SystemQAU · Traditional | Hemostasis, LLC | 07/26/2024SE |
| K202929 | NexpowderQAU · Traditional | Nextbiomedical Co., Ltd. | 09/16/2022SE |
| K210098 | PuraStat-GIQAU · Traditional | 3-D Matrix, Inc. | 06/25/2021SE |
| K190677 | EndoClotQAU · Traditional | Endoclot Plus Co., Ltd. | 01/29/2021SE |
| K200972 | Hemospray Endoscopic HemostatQAU · Traditional | Wilson-Cook Medical, Inc. | 06/10/2020SE |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261504 | PuraStat-RMPHN · Traditional | 08/03/2026SE |
| K261503 | PuraStat GIQAU · Traditional | 08/03/2026SE |
| K213552 | PuraStat-RMPHN · Traditional | 04/01/2022SE |
| K210211 | PuraStat-OMOLR · Traditional | 10/08/2021SE |
| K210098 | PuraStat-GIQAU · Traditional | 06/25/2021SE |
| K193085 | PuraDERM GelFRO · Traditional | 05/11/2020SE |
| K183015 | PuraSinusNHB · Traditional | 04/12/2019SE |
| K143058 | PuraDerm GelFRO · Traditional | 02/13/2015SE |
Questions and answers
When was PuraStat cleared by the FDA?
PuraStat (K222481) received a 510(k) decision of Substantially Equivalent on February 28, 2023, 195 days after the submission was received.
What is the product code of K222481?
The FDA product code is QAU – Hemostatic Device For Endoscopic Gastrointestinal Use, a Class II (moderate risk) device regulated under 21 CFR 878.4456.