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FDA 510(k)

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000

K-Number: K211490 · 2021-06-09

ApplicantStryker Corporation
Decision Date2021-06-09
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2021-06-09 under approval number K211490. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000?

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 is a medical device that received FDA 510(k) clearance on 2021-06-09. It is manufactured by Stryker Corporation. The 510(k) number is K211490.

When was Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 approved by the FDA?

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 received FDA 510(k) clearance on 2021-06-09, under approval number K211490.

What company makes Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000?

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 is manufactured by Stryker Corporation.

What is the FDA product code for Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000?

The FDA product code for Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 is ERL.

Related Clinical Trials

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

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Related Devices (Code: ERL)

K161376DragonFly Surgical Drill SystemGrace Medical, Inc. K161101PolypVac Microdebrider (3.3mm and 4.0mm)Laurimed, LLC K152744DIEGO ELITE DRILLGyrus Acmi, Inc. K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill HandpiecesKarl Storz Endoscopy America, Inc. K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Corporation K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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