510(k) K234131

Resolv Endoscopic Hemostat System by Hemostasis, LLC — Product Code QAU

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.

Other clearances by Hemostasis, LLC

K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint (November 14, 2022)
K210411 — PosiSep EAR Fragmentable Ear Dressing (May 5, 2022)
K142348 — OsteoSeal Bone Hemostat (January 23, 2015)
K122494 — POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT (March 27, 2013)
K122886 — NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING (November 15, 2012)
K120958 — POSISEP AND POSISEP X HEMOSTAT DRESSINGS (July 25, 2012)
K102459 — NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE (December 3, 2010)
K072900 — EXCELARREST FOAM (October 26, 2007)
K070211 — TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM (April 5, 2007)

Other clearances for product code QAU

K253924 — PuraStat (January 7, 2026)
K240994 — Nexpowder (November 27, 2024)
K242250 — PuraStat (October 22, 2024)
K222481 — PuraStat (February 28, 2023)
K202929 — Nexpowder (September 16, 2022)
K210098 — PuraStat-GI (June 25, 2021)
K190677 — EndoClot (January 29, 2021)
K200972 — Hemospray Endoscopic Hemostat (June 10, 2020)
DEN170015 — Hemospray Endoscopic Hemostat (May 7, 2018)