VISITEC PRECISE-POINT
Device Facts
| Record ID | K942234 |
|---|---|
| Device Name | VISITEC PRECISE-POINT |
| Applicant | Visitec Co. |
| Product Code | GAP · General, Plastic Surgery |
| Decision Date | Jul 12, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5030 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
