Skip to content

Pi Drive Plus Motor Extender

by Stryker Corporation

510(k) K152641

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 · Special NumberK152641 Date20 Nov 2015ClearedStatusActive

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  • Withdrawn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, 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 Pi Drive Plus Motor Extender is a surgical drill, including a handpiece, that is electric or pneumatic. It is used in ear, nose, and throat procedures.

The device is supplied with various registration numbers and is classified as a class 2 device. It has an FDA 510K authorization and is regulated under regulation number 874.4250. The device is intended for use in a medical setting, specifically in ear, nose, and throat procedures.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

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 Pi Drive Plus Motor Extender used for?

    The Pi Drive Plus Motor Extender is used in ear, nose, and throat procedures as a surgical drill, including a handpiece, that is electric or pneumatic.

  • Is the Pi Drive Plus Motor Extender supplied sterile?

    The device data does not specify if the Pi Drive Plus Motor Extender is supplied sterile, but it is intended for use in a medical setting.

  • What is the regulatory classification of the Pi Drive Plus Motor Extender?

    The Pi Drive Plus Motor Extender is classified as a class 2 device and is regulated under regulation number 874.4250.