PICO— 510(k) K111170
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K111170 for PICO, Substantially Equivalent on 2011-12-15. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Product 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
Recent devices under product code OMP
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- K261982 — RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)
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- K261338 — RENASYS DYNAFLOW Kit (66807741)
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More clearances from Smith & Nephew, Inc.
view all- K263461 — Tendon Anchor
- K263348 — Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue +5 more
- K261462 — LANDMARK Total Knee System
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
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.