Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing— 510(k) K202783
Substantially EquivalentSmith & Nephew Medical Limited
FDA 510(k) clearance K202783 for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing, Substantially Equivalent on 2022-01-14. Applicant: Smith & Nephew Medical Limited. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew Medical Limited
- 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
- Hull, GB
Recent devices under product code OMP
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view all- K242146 — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
- K223526 — ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
- K220964 — VERSAJET Hydrosurgery System (III)
- K223041 — Renasys Edge (66803126)
- K211318 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.