21 C.F.R. § 878.4495 Stainless steel suture.
Title 21 - Food and Drugs
(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. [65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003]
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices
§ 878.4495 Stainless steel suture.
