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UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

by Karl Storz Endoscopy-America, Inc.

510(k) K200318

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200318 Date22 Oct 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
ERL
Device Class
Class II
Regulation
21 CFR Part 874.4250
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The device is a surgical drill and shaver handpiece system intended for use in ear, nose, and throat procedures. It is classified as a Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece under FDA regulation number 874.4250.

The system received FDA 510(k) clearance (K200318) on October 22, 2020, as substantially equivalent to a predicate device. It is supplied as a reusable handpiece component of the UNIDRIVE S II ENT system and is intended for use by qualified surgeons in clinical settings for controlled cutting, drilling, debriding, sawing, and shaving during ablation procedures.

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Questions

AI-generated answers, 1 Oct 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 UNIDRIVE S II ENT DrillCut-X II-35 Shaver Handpiece used for?

    The UNIDRIVE S II ENT DrillCut-X II-35 Shaver Handpiece is a reusable surgical handpiece system designed for ear, nose, and throat procedures. It enables qualified surgeons to perform controlled cutting, drilling, debriding, sawing, and shaving during ablation procedures in clinical settings.

  • How is the UNIDRIVE S II ENT DrillCut-X II-35 Shaver Handpiece supplied?

    The handpiece is supplied as a reusable component of the UNIDRIVE S II ENT system. It is designed for repeated use in clinical settings when properly sterilized according to the manufacturer's instructions.

  • What regulatory status does the UNIDRIVE S II ENT DrillCut-X II-35 Shaver Handpiece have?

    The device received FDA 510(k) clearance (K200318) on October 22, 2020, as substantially equivalent to a predicate device. It is classified as a Drill, Surgical, ENT (Electric or Pneumatic) Including Handpiece under FDA regulation number 874.4250.

  • What are the different models of the UNIDRIVE S II ENT DrillCut-X II-35 Shaver Handpiece available?

    The system includes two models: the DrillCut-X II-35 Shaver Handpiece and the DrillCut-X II-35 N Shaver Handpiece. Both are designed for use with the UNIDRIVE S II ENT system and serve the same clinical functions.