SELUnclassified
Securement Wound Dressing For Reduction Of Infection
Unknown
SEL is the FDA product code for Securement Wound Dressing For Reduction Of Infection. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SEL
- Device name
- Securement Wound Dressing For Reduction Of Infection
- FDA 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).
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code SEL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2017 | 2 |
Applicants with the most clearances
Product code SEL| Applicant | Clearances |
|---|---|
| 3M Company | 2 |
| Integra LifeSciences Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.