21 CFR 874.3760 — Tack, Sacculotomy (Cody Tack)
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3760
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ESX | Tack, Sacculotomy (Cody Tack) | 2 | 1 | Implant |
