ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE
Device Facts
| Record ID | K896310 |
|---|---|
| Device Name | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE |
| Applicant | Acufex Microsurgical, Inc. |
| Product Code | KGS · General, Plastic Surgery |
| Decision Date | Nov 20, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4930 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.