Resolv Endoscopic Hemostat System— 510(k) K234131

Name: FDA 510(k) clearance K234131
Creator: U.S. Food and Drug Administration
Published: 2024-07-26

Substantially Equivalent

Hemostasis, LLC

FDA 510(k) clearance K234131 for Resolv Endoscopic Hemostat System, Substantially Equivalent on 2024-07-26. Applicant: Hemostasis, LLC. Device class: 2.

Clearance details

Applicant: Hemostasis, LLC
Product code: Code QAU
Device class: Class 2
Regulation: 21 CFR 878.4456
Advisory panel: General, Plastic Surgery
Date received: 2023-12-28
Decision date: 2024-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAU

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K261503 — PuraStat GI2026-08-03
K253302 — Hemospray Endoscopic Hemostat (HEMO-[X])2026-06-02
K253924 — PuraStat2026-01-07
K240994 — Nexpowder2024-11-27
K242250 — PuraStat2024-10-22

More clearances from Hemostasis, LLC

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K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint2022-11-14
K210411 — PosiSep EAR Fragmentable Ear Dressing2022-05-05
K142348 — OsteoSeal Bone Hemostat2015-01-23
K122494 — POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT2013-03-27
K122886 — NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING2012-11-15

Adverse events under product code QAU

product code QAU

Death: 6
Injury: 135
Malfunction: 621
Total: 762

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.