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C-Flex Endolymphatic Shunt

by Trebay Medical Corp.

510(k) K952227

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952227 Date16 Jun 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ESZ
Device Class
Class II
Regulation
21 CFR Part 874.3820
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A tube, shunt, endolymphatic device used in the ear, nose, and throat medical specialty. It is designed to drain endolymphatic fluid from the inner ear to alleviate symptoms associated with Ménière's disease.

Supplied as a sterile, single-use implantable device. It is regulated under FDA 510(k) clearance K952227, classified as a Class II device with product code ESZ, and indicated for use in otologic surgical procedures.

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