GroundRules
21 CFR 874.3760: Sacculotomy tack (Cody tack)
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 874—EAR, NOSE, AND THROAT DEVICES
- Subpart D—Prosthetic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON