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FDA 510(k)

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

K-Number: K150969 · 2016-01-08

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2016-01-08
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2016-01-08 under approval number K150969. 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 Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces?

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces is a medical device that received FDA 510(k) clearance on 2016-01-08. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K150969.

When was Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces approved by the FDA?

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces received FDA 510(k) clearance on 2016-01-08, under approval number K150969.

What company makes Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces?

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces is manufactured by Karl Storz Endoscopy America, Inc..

What is the FDA product code for Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces?

The FDA product code for Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces is ERL.

Related Clinical Trials

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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. K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Corporation K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC K180063OCM-G1 AttachmentThe Anspach Effort, Inc.

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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