PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack— 510(k) K202157
Substantially EquivalentSmith & Nephew Medical Limited
FDA 510(k) clearance K202157 for PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack, Substantially Equivalent on 2020-10-30. 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
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- K220964 — VERSAJET Hydrosurgery System (III)
- K223041 — Renasys Edge (66803126)
- K202783 — Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
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.