NuStat

FDA 510(k) K183190 · Beeken Biomedical, LLC

Substantially Equivalent

510(k) numberK183190

Submission

Device name
NuStat
Applicant
Beeken Biomedical, LLC
Stoughton, MA, US
Received
November 19, 2018
Decision date
September 25, 2019
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

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K243553QuikClot Control+ Hemostatic DevicePOD · Traditional Teleflex Medical03/18/2025SE
K213198Ax-Surgi Surgical HemostatPOD · Traditional Advamedica, Inc.01/05/2023SE
K220971QuikClot Control+ Hemostatic DressingPOD · Traditional Z-Medica, LLC12/14/2022SE
K200167QuikClot Control+POD · Traditional Z-Medica, LLC04/23/2020SE

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Questions and answers

When was NuStat cleared by the FDA?

NuStat (K183190) received a 510(k) decision of Substantially Equivalent on September 25, 2019, 310 days after the submission was received.

What is the product code of K183190?

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