FLEXON AND STAINLESS STEEL SUTURES
Device Facts
| Record ID | K930992 |
|---|---|
| Device Name | FLEXON AND STAINLESS STEEL SUTURES |
| Applicant | American Cyanamid Co. |
| Product Code | GAQ · General, Plastic Surgery |
| Decision Date | Dec 17, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4495 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.
Special Controls
*Classification.* Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.
