ACTICOAT Surgical Dressing— 510(k) K153723
Substantially EquivalentSmith & Nephew Medical Limited
FDA 510(k) clearance K153723 for ACTICOAT Surgical Dressing, Substantially Equivalent on 2016-09-14. Applicant: Smith & Nephew Medical Limited. Device class: Unclassified.
Clearance details
- Applicant
- Smith & Nephew Medical Limited
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hull, GB
Recent devices under product code FRO
view allMore clearances from Smith & Nephew Medical Limited
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)
- K202783 — Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
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.