Karl Storz UROMAT E.A.S.I.
K-Number: K162992 · 2017-07-07
ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2017-07-07
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Karl Storz UROMAT E.A.S.I. is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2017-07-07 under approval number K162992. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Karl Storz UROMAT E.A.S.I.?
Karl Storz UROMAT E.A.S.I. is a medical device that received FDA 510(k) clearance on 2017-07-07. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K162992.
When was Karl Storz UROMAT E.A.S.I. approved by the FDA?
Karl Storz UROMAT E.A.S.I. received FDA 510(k) clearance on 2017-07-07, under approval number K162992.
What company makes Karl Storz UROMAT E.A.S.I.?
Karl Storz UROMAT E.A.S.I. is manufactured by Karl Storz Endoscopy America, Inc..
What is the FDA product code for Karl Storz UROMAT E.A.S.I.?
The FDA product code for Karl Storz UROMAT E.A.S.I. is LJH.
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K162410TIPCAM 1S 3D System
K180146KARL STORZ ICG Imaging System
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.