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FDA 510(k)

npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™

Número K: K201400 · 2021-08-23

RequerenteAatru Medical, LLC
Data da decisão2021-08-23
Código do produtoQPX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ is the device name listed in this FDA 510(k) record. The listed applicant is Aatru Medical, LLC. It received FDA 510(k) clearance on 2021-08-23 under 510(k) number K201400. The device is classified under product code QPX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™?

npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ is a medical device that received FDA 510(k) clearance on 2021-08-23. The listed applicant is Aatru Medical, LLC. The 510(k) number is K201400.

When did npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ receive FDA 510(k) clearance?

npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ received FDA 510(k) clearance on 2021-08-23, under 510(k) number K201400.

Who is the listed applicant for npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™?

The FDA 510(k) record lists Aatru Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™?

The FDA product code for npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ is QPX.

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Fonte oficial

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