DIEGO ELITE DRILL
K-Number: K152744 · 2016-06-10
ApplicantGyrus Acmi, Inc.
Decision Date2016-06-10
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
DIEGO ELITE DRILL is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2016-06-10 under approval number K152744. 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 DIEGO ELITE DRILL?
DIEGO ELITE DRILL is a medical device that received FDA 510(k) clearance on 2016-06-10. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K152744.
When was DIEGO ELITE DRILL approved by the FDA?
DIEGO ELITE DRILL received FDA 510(k) clearance on 2016-06-10, under approval number K152744.
What company makes DIEGO ELITE DRILL?
DIEGO ELITE DRILL is manufactured by Gyrus Acmi, Inc..
What is the FDA product code for DIEGO ELITE DRILL?
The FDA product code for DIEGO ELITE DRILL is ERL.
Other Devices by Gyrus Acmi, Inc.
Related Devices (Code: ERL)
K161376DragonFly Surgical Drill SystemGrace Medical, Inc.
K161101PolypVac Microdebrider (3.3mm and 4.0mm)Laurimed, LLC
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.