§ 878.4495. Stainless steel suture.
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/us/cfr/t21/s§ 878.4495·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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 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. [65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003; 84 FR 71814, Dec. 30, 2019]
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§ 878.4495
Stainless steel suture.
Fed. Reg.×1
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