FDA 510(k)

PolypVac Microdebrider (3.3mm and 4.0mm)

K-Number: K161101 · 2016-06-22

Decision Date2016-06-22

Product CodeERL

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PolypVac Microdebrider (3.3mm and 4.0mm) is a medical device manufactured by Laurimed, LLC. It received FDA 510(k) clearance on 2016-06-22 under approval number K161101. 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 PolypVac Microdebrider (3.3mm and 4.0mm)?

PolypVac Microdebrider (3.3mm and 4.0mm) is a medical device that received FDA 510(k) clearance on 2016-06-22. It is manufactured by Laurimed, LLC. The 510(k) number is K161101.

When was PolypVac Microdebrider (3.3mm and 4.0mm) approved by the FDA?

PolypVac Microdebrider (3.3mm and 4.0mm) received FDA 510(k) clearance on 2016-06-22, under approval number K161101.

What company makes PolypVac Microdebrider (3.3mm and 4.0mm)?

PolypVac Microdebrider (3.3mm and 4.0mm) is manufactured by Laurimed, LLC.

What is the FDA product code for PolypVac Microdebrider (3.3mm and 4.0mm)?

The FDA product code for PolypVac Microdebrider (3.3mm and 4.0mm) is ERL.

Other Devices by Laurimed, LLC

K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider

Related Devices (Code: ERL)

K161376DragonFly Surgical Drill SystemGrace Medical, Inc. 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 K180063OCM-G1 AttachmentThe Anspach Effort, Inc.

Official Source

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