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DRG Laryngeal Augmentation Implant Device

by Doctor'S Research Group, Inc. 510(k)

Active United States

510(k) K051487

Overview

The DRG Laryngeal Augmentation Implant Device is a polymer, ENT synthetic-polyamide mesh or foil material implant. It is classified under regulation number 874.3620 and product code KHJ, and is indicated for use in the ear, nose, and throat medical specialty.

The device received FDA 510(k) clearance under K051487 on December 22, 2005, following a traditional review process. It was found substantially equivalent to a predicate device and is manufactured by Doctor'S Research Group, Inc. in Plymouth, CT. The device is supplied as a single implant and is intended for use in laryngeal augmentation procedures.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051487 Date22 Dec 2005ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KHJ
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the DRG Laryngeal Augmentation Implant Device used for?

    The device is indicated for use in laryngeal augmentation procedures within the ear, nose, and throat medical specialty, as a synthetic-polyamide mesh or foil implant to support tissue volume.

  • How is the DRG Laryngeal Augmentation Implant Device supplied and is it reusable?

    The device is supplied as a single implant per unit and is intended for single-use only; it is not designed for cleaning, sterilization, or reuse after implantation.

  • What material is the DRG Laryngeal Augmentation Implant Device made from and what is its regulatory classification?

    The device is made of polymer, ENT synthetic-polyamide mesh or foil material and is classified under regulation number 874.3620 with product code KHJ, falling under FDA class II devices based on its 510(k) clearance.