KENSORB
Device Facts
| Record ID | K953830 |
|---|---|
| Device Name | KENSORB |
| Applicant | Kentron Health Care, Inc. |
| Product Code | GDY · General, Plastic Surgery |
| Decision Date | Oct 3, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4450 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.
