510(k) clearance
RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
- 510(k) number
- K260306
- Applicant
- Smith & Nephew Medical, Ltd.
- Decision date
- Oct 30, 2026
- Date received
- Jan 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OMP
- Device type
- Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II
- Regulation
- 21 CFR 878.4780
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Hull, GB