Resolv Endoscopic Hemostat System
FDA 510(k) K234131 · Hemostasis, LLC
510(k) numberK234131
Submission
- Device name
- Resolv Endoscopic Hemostat System
- Applicant
- Hemostasis, LLC
St. Paul, MN, US - Received
- December 28, 2023
- Decision date
- July 26, 2024
- 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 |
| K222481 | PuraStatQAU · Traditional | 3-D Matrix, Inc. | 02/28/2023SE |
| 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 |
|---|---|---|
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal SplintEMX · Traditional | 11/14/2022SE |
| K210411 | PosiSep EAR Fragmentable Ear DressingNHB · Traditional | 05/05/2022SE |
| K142348 | OsteoSeal Bone HemostatMTJ · Traditional | 01/23/2015SE |
| K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal SplintLYA · Traditional | 03/27/2013SE |
| K122886 | Nexstat Plus and Nexfoam Plus Topical Hemostat DressingQSY · Special | 11/15/2012SE |
| K120958 | Posisep and Posisep X Hemostat DressingsQSY · Traditional | 07/25/2012SE |
| K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeQSY · Traditional | 12/03/2010SE |
| K072900 | Excelarrest FoamQSY · Special | 10/26/2007SE |
| K070211 | Traumarrest and Bleedarrest Hemostatic Particles and FoamQSY · Traditional | 04/05/2007SE |
Questions and answers
When was Resolv Endoscopic Hemostat System cleared by the FDA?
Resolv Endoscopic Hemostat System (K234131) received a 510(k) decision of Substantially Equivalent on July 26, 2024, 211 days after the submission was received.
What is the product code of K234131?
The FDA product code is QAU – Hemostatic Device For Endoscopic Gastrointestinal Use, a Class II (moderate risk) device regulated under 21 CFR 878.4456.