21 CFR § 878.4760
Removable skin staple
June 25, 2020
(a) Identification. A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.
(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 §878.9.
[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]