Clearance Summary
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister received FDA 510(k) clearance under submission number K143362, sponsored by Devon Medical Products. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2015-02-03.
- Submission: K143362
- Applicant / Sponsor: Devon Medical Products
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2015-02-03
Classification & Regulation
This clearance is catalogued under FDA product code OMP and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.