[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4495]

[Page 402]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878_GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E_Surgical Devices
 
Sec. 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 Sec. 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]