Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider

K-Number: K163247 · 2017-03-09

ApplicantLaurimed, LLC
Decision Date2017-03-09
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider is a medical device manufactured by Laurimed, LLC. It received FDA 510(k) clearance on 2017-03-09 under approval number K163247. 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 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider?

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider is a medical device that received FDA 510(k) clearance on 2017-03-09. It is manufactured by Laurimed, LLC. The 510(k) number is K163247.

When was 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider approved by the FDA?

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider received FDA 510(k) clearance on 2017-03-09, under approval number K163247.

What company makes 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider?

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider is manufactured by Laurimed, LLC.

What is the FDA product code for 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider?

The FDA product code for 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider is ERL.

Other Devices by Laurimed, LLC

K161101PolypVac Microdebrider (3.3mm and 4.0mm)

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 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.

↑