§ 878.5020. Nonabsorbable polyamide surgical suture.
145 words·~1 min read·
/us/cfr/t21/s§ 878.5020·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
(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. [56 FR 24685, May 31, 1991, as amended at 68 FR 32985, June 3, 2003]
Connections1 cite this
Cited by 1 section
register
Citation graph
cites case law
§ 878.5020
Nonabsorbable polyamide surgical suture.
Fed. Reg.×1
Cites 0Cited by 1 across 1 source