SEL — Securement Wound Dressing For Reduction Of Infection Class U
FDA product code SEL covers "Securement Wound Dressing For Reduction Of Infection", a Class U medical device. Submissions are reviewed by the SU panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SEL
- Device Class
- Class U
- Submission Type
- 510(k)
- Review Panel
- SU
- Implant
- No
Definition
These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used to secure central venous or arterial catheters, a securement wound dressing for reduction of infection is intended to reduce microbial colonization around the insertion site and reduce the incidence of catheter-related bloodstream infections (CRBSI).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171908 | 3M | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | Jul 11, 2017 |
| K153410 | 3M | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | May 15, 2017 |
| K003229 | Integra Lifesciences | BIOPATCH ANTIMICROBIAL DRESSING | Oct 26, 2001 |