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FDA 510(k)

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

K-Number: K201400 · 2021-08-23

ApplicantAatru Medical, LLC
Decision Date2021-08-23
Product CodeQPX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07770633Negative Pressure Wound Therapy Devices in Total Knee ArthroplastyNOT_YET_RECRUITINGNCT06025253PINTA - Prophylactic Incisional Negative Pressure Therapy for Major AmputationsRECRUITINGNCT06337292Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk FracturesRECRUITINGNCT06661473Interventional Study Exploring the Occurrence of Surgical Site Infections.COMPLETED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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