(a)Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]