Resolv Endoscopic Hemostat System— 510(k) K234131

Substantially Equivalent

Hemostasis, LLC

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

Clearance details

Applicant: Hemostasis, LLC
Product code: Code QAU
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 ↗

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.