Cleared Traditional

K172324 - Axiostat Chitosan Hemostatic Dressing

K172324 · Advamedica, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
206d
Days
-
Risk

K172324 is an FDA 510(k) clearance for the Axiostat Chitosan Hemostatic Dressing. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Advamedica, Inc. (Cambridge, US). The FDA issued a Cleared decision on February 23, 2018 after a review of 206 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Advamedica, Inc. devices

FDA 510(k) Submission Details - K172324

510(k) Number K172324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2017
Decision Date February 23, 2018
Days to Decision 206 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 115d · This submission: 206d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Consultant

Matrix Medical Consulting, Inc.
Alan Donald

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 29
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K172324.
IHM Technology Bandage
K180893 · Protege Biomedical · Sep 2018
gel-e Flex
K180152 · Gel-E, Inc. · Jun 2018
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
K172155 · Statguard, LLC · Apr 2018
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004