ACTICOAT FLEX 7 DRESSING— 510(k) K083113
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K083113 for ACTICOAT FLEX 7 DRESSING, Substantially Equivalent on 2009-07-22. Applicant: Smith & Nephew, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Petersburg, FL, US
Recent devices under product code FRO
view allMore 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 FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.