878.4495—Stainless steel suture.

(a) 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.

(b) 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.

Code of Federal Regulations

[65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003]

CFR

878.4495—Stainless steel suture.

Code of Federal Regulations