510(k) K201400

Device

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

Applicant

Aatru Medical, LLC

510(k) number

K201400

Product code

QPX

Decision

Substantially Equivalent (SESE)

Decision date

2021-08-23

Date received

2020-05-28

Regulation

878.4683

Classification name

Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical

Medical specialty

General, Plastic Surgery

Review panel

General, Plastic Surgery

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No