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Vocom Silicone System

by Smith & Nephew, Inc.

510(k) K001466

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 NumberK001466 Date26 Jul 2000ClearedStatusActive

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  • Withdrawn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
MIX
Device class
Class II
Regulation
21 CFR Part 874.3620
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Vocom Silicone System is a vocal cord medialization system. It is designed to assist in the surgical treatment of vocal cord conditions.

This device is regulated as a Class 2 medical device under regulation number 874.3620. It has received FDA 510k clearance.

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Questions

AI-generated answers, 23 Sep 2026

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

  • What is the primary purpose of the Vocom Silicone System?

    The Vocom Silicone System is designed to assist clinicians in the surgical treatment of vocal cord conditions by providing a medialization system for the vocal cords.

  • How is the Vocom Silicone System regulated?

    This device is regulated as a Class 2 medical device under regulation number 874.3620 and has received FDA 510k clearance, indicating it has been found substantially equivalent to legally marketed predicate devices.

  • Which medical specialty uses the Vocom Silicone System?

    The system is categorized under the Ear, Nose, and Throat medical specialty, reflecting its intended use in surgical procedures involving the vocal cords.