21 CFR § 874.3760 - Sacculotomy tack (Cody tack)
(a) Identification. A sacculotomy tack (Cody tack) is a device that consists of a pointed stainless steel tack intended to be implanted to relieve the symptoms of vertigo. The device repetitively ruptures the utricular membrane as the membrane expands under increased endolymphatic pressure.
(b) Classification. Class II.