FDA 510(k)

npSIMS Negative Pressure Surgical Incision Management System (npSIMS)

K-Number: K201400 · 2021-08-23

Decision Date2021-08-23

Product CodeQPX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

npSIMS Negative Pressure Surgical Incision Management System (npSIMS) is a medical device manufactured by Aatru Medical, LLC. It received FDA 510(k) clearance on 2021-08-23 under approval 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. It is manufactured by Aatru Medical, LLC. The 510(k) number is K201400.

When was npSIMS Negative Pressure Surgical Incision Management System (npSIMS) approved by the FDA?

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

What company makes npSIMS Negative Pressure Surgical Incision Management System (npSIMS)?

npSIMS Negative Pressure Surgical Incision Management System (npSIMS) is manufactured by Aatru Medical, LLC.

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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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020) PMID: 26056630 Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. International journal of spine surgery (2015)

Official Source

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