510(k) K234131
K234131 is an FDA 510(k) premarket notification submitted by Hemostasis, LLC for the device "Resolv Endoscopic Hemostat System". The FDA issued a decision of Substantially Equivalent on July 26, 2024. The device falls under product code QAU (Hemostatic Device For Endoscopic Gastrointestinal Use), a Class II device regulated under 21 CFR 878.4456. Hemostasis, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2024
- Date Received
- December 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostatic Device For Endoscopic Gastrointestinal Use
- Device Class
- Class II
- Regulation Number
- 878.4456
- Review Panel
- SU
- Submission Type
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.