Nexpowder— 510(k) K240994

Name: FDA 510(k) clearance K240994
Creator: U.S. Food and Drug Administration
Published: 2024-11-27

Substantially Equivalent

Nextbiomedical Co., Ltd.

FDA 510(k) clearance K240994 for Nexpowder, Substantially Equivalent on 2024-11-27. Applicant: Nextbiomedical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nextbiomedical Co., Ltd.
Product code: Code QAU
Device class: Class 2
Regulation: 21 CFR 878.4456
Advisory panel: General, Plastic Surgery
Date received: 2024-04-11
Decision date: 2024-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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K253302 — Hemospray Endoscopic Hemostat (HEMO-[X])2026-06-02
K253924 — PuraStat2026-01-07
K242250 — PuraStat2024-10-22
K234131 — Resolv Endoscopic Hemostat System2024-07-26

More clearances from Nextbiomedical Co., Ltd.

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K202929 — Nexpowder2022-09-16

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.