RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD— 510(k) K110647
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K110647 for RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD, Substantially Equivalent on 2011-06-22. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Device name as filed
- RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Petersburg, FL, US
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Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110647
K-number listed on FDA's recall record- Z-1157-2014 — Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
- Z-1158-2014 — Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
- Z-1159-2014 — Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
- Z-1160-2014 — Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
- Z-1161-2014 — Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
- Z-1162-2014 — Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110647.
Data sourced from openFDA. This site is unofficial and independent of the FDA.