510(k) K201400
K201400 is an FDA 510(k) premarket notification submitted by Aatru Medical, LLC for the device "npSIMS Negative Pressure Surgical Incision Management System (npSIMS)". The FDA issued a decision of Substantially Equivalent on August 23, 2021. The device falls under product code QPX (Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical), a Class II device regulated under 21 CFR 878.4683.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2021
- Date Received
- May 28, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
- Device Class
- Class II
- Regulation Number
- 878.4683
- Review Panel
- SU
- Submission Type
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.