Ax-Surgi Surgical Hemostat

FDA 510(k) K213198 · Advamedica, Inc.

Substantially Equivalent

510(k) numberK213198

Submission

Device name
Ax-Surgi Surgical Hemostat
Applicant
Advamedica, Inc.
Cambridge, MA, US
Received
September 29, 2021
Decision date
January 5, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
POD – Temporary, Internal Use Hemostatic
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4454
Specialty
General, Plastic Surgery
Life-sustaining
Yes

Intended to control severely bleeding wounds

Other 510(k)s with product code POD

510(k)DeviceApplicantDecision
K243553QuikClot Control+ Hemostatic DevicePOD · Traditional Teleflex Medical03/18/2025SE
K220971QuikClot Control+ Hemostatic DressingPOD · Traditional Z-Medica, LLC12/14/2022SE
K200167QuikClot Control+POD · Traditional Z-Medica, LLC04/23/2020SE
K183190NuStatPOD · Traditional Beeken Biomedical, LLC09/25/2019SE

More from Beeken Biomedical, LLC

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K212766Maxiocel Chitosan Wound DressingKGN · Traditional 08/24/2023SE
K222909Axiostat GauzeQSY · Traditional 04/07/2023SE
K202830Axiostat PatchQSY · Traditional 04/15/2021SE
K172324Axiostat Chitosan Hemostatic DressingQSY · Traditional 02/23/2018SE

Questions and answers

When was Ax-Surgi Surgical Hemostat cleared by the FDA?

Ax-Surgi Surgical Hemostat (K213198) received a 510(k) decision of Substantially Equivalent on January 5, 2023, 463 days after the submission was received.

What is the product code of K213198?

The FDA product code is POD – Temporary, Internal Use Hemostatic, a Class II (moderate risk) device regulated under 21 CFR 878.4454.