ESX · Tack, Sacculotomy (Cody Tack)
Ear, Nose, Throat · 21 CFR 874.3760 · Class 2
Overview
| Product Code | ESX |
|---|---|
| Device Name | Tack, Sacculotomy (Cody Tack) |
| Regulation | 21 CFR 874.3760 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832068 | CODY SACCULOTOMY TACK | Micromedics, Inc. | Oct 19, 1983 | SESE |
Top Applicants
- Micromedics, Inc. — 1 clearance
