Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3760](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3760) → ESX — Tack, Sacculotomy (Cody Tack)

# ESX · Tack, Sacculotomy (Cody Tack)

_Ear, Nose, Throat · 21 CFR 874.3760 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESX

## Overview

- **Product Code:** ESX
- **Device Name:** Tack, Sacculotomy (Cody Tack)
- **Regulation:** [21 CFR 874.3760](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3760)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **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](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESX/K832068.md) | CODY SACCULOTOMY TACK | Micromedics, Inc. | Oct 19, 1983 | SESE |

## Top Applicants

- Micromedics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESX](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESX)

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