Title 21

SECTION 878.4830

878.4830 Absorbable surgical gut suture.

§ 878.4830 Absorbable surgical gut suture.

(a) Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

(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.

[54 FR 50738, Dec. 11, 1989, as amended at 68 FR 32984, June 3, 2003]

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