Axiostat Chitosan Hemostatic Dressing— 510(k) K172324

Name: FDA 510(k) clearance K172324
Creator: U.S. Food and Drug Administration
Published: 2018-02-23

Substantially Equivalent

Advamedica, Inc.

FDA 510(k) clearance K172324 for Axiostat Chitosan Hemostatic Dressing, Substantially Equivalent on 2018-02-23. Applicant: Advamedica, Inc.. Device class: Unclassified.

Clearance details

Applicant: Advamedica, Inc.
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2017-08-01
Decision date: 2018-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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K251700 — Ganymede 2cm diameter (FG100300) +14 more2026-02-26
K250319 — MFUSE (MS001)2025-12-15
K253609 — TRAUMAGEL® 2.0 Hemostatic Gel2025-12-12
K240713 — TRAUMAGEL®2024-08-14

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K212766 — Maxiocel Chitosan Wound Dressing2023-08-24
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K213198 — Ax-Surgi Surgical Hemostat2023-01-05
K202830 — Axiostat Patch2021-04-15

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.