FDA product code SEL: Securement Wound Dressing For Reduction Of Infection
SEL is the FDA product code for securement wound dressing for reduction of infection. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under SEL, from 2 different applicants. The average 510(k) review took 311 days (median 381).
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).
Classification
| Field | Value |
|---|---|
| Device name | Securement Wound Dressing For Reduction Of Infection |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for SEL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 276 |
Compare with all 510(k) review times · Search every SEL clearance
Top SEL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M Company | 2 | 2017-07-11 |
| Integra Lifesciences Corp. | 1 | 2001-10-26 |
Most recent SEL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171908 | 3M Company | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 2017-07-11 | 15 |
| K153410 | 3M Company | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 2017-05-15 | 537 |
| K003229 | Integra Lifesciences Corp. | BIOPATCH ANTIMICROBIAL DRESSING | 2001-10-26 | 381 |
Recalls for SEL devices
openFDA lists no recalls for product code SEL.
Frequently asked questions
What is FDA product code SEL?
SEL is the FDA product code for securement wound dressing for reduction of infection. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is SEL?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEL?
Across 3 cleared submissions the average was 311 days from receipt to decision (median 381).
Which companies have the most SEL clearances?
3M Company (2); Integra Lifesciences Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SEL
- Run a recall and safety report across every SEL manufacturer
- Watch product code SEL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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