CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 878—GENERAL AND PLASTIC SURGERY DEVICES > SUBPART E—Surgical Devices (§878.4010 to §878.5040) > 878.4495—Stainless steel suture.

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]