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FDA 510(k)

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

K-Number: K200318 · 2020-10-22

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2020-10-22
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2020-10-22 under approval number K200318. 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 II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece?

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece is a medical device that received FDA 510(k) clearance on 2020-10-22. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K200318.

When was UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece approved by the FDA?

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece received FDA 510(k) clearance on 2020-10-22, under approval number K200318.

What company makes UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece?

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece is manufactured by KARL STORZ Endoscopy-America, Inc..

What is the FDA product code for UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece?

The FDA product code for UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece is ERL.

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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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