510(k) K212359
K212359 is an FDA 510(k) premarket notification submitted by Applied Tissue Technologies, LLC for the device "PWD Negative Pressure Wound Therapy System". The FDA issued a decision of Substantially Equivalent on Sep 21, 2022. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Applied Tissue Technologies, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2022
- Date Received
- Jul 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Negative Pressure Wound Therapy Powered Suction Pump
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type
- 510(k)
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. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.