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XPS Drill System

by Xomed, Inc. 510(k)

Active United States

510(k) K983224

Overview

The XPS Drill System is a surgical drill, ENT (electric or pneumatic) including handpiece, intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It is also intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

The device is supplied as a system and is regulated under FDA 510(k) clearance K983224. It is classified as a class II medical device under regulation number 874.4250 and product code ERL. The system is manufactured by Xomed, Inc. in Jacksonville, Florida, and was granted substantial equivalence on October 21, 1998.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983224 Date21 Oct 1998ClearedStatusActive

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
ERL
Device Class
Class II
Regulation
21 CFR Part 874.4250
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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See all devices from Xomed, Inc. →

Questions

  • What is the XPS Drill System intended for?

    The XPS Drill System is intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It is also intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

  • How is the XPS Drill System supplied and what is its regulatory status?

    The XPS Drill System is supplied as a complete system and is regulated under FDA 510(k) clearance K983224. It was granted substantial equivalence on October 21, 1998, and is classified as a class II medical device under regulation number 874.4250 and product code ERL.

  • Who manufactures the XPS Drill System and where is it made?

    The XPS Drill System is manufactured by Xomed, Inc. in Jacksonville, Florida, United States. The manufacturer's address is 6743 Southpoint Dr. N., Jacksonville, FL 32216.