510(k) K203693
K203693 is an FDA 510(k) premarket notification submitted by Cork Medical Products, LLC for the device "Nisus Touch Negative Pressure Wound Therapy Pump". The FDA issued a decision of Substantially Equivalent on Aug 13, 2021. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Cork Medical Products, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2021
- Date Received
- Dec 18, 2020
- 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.