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FDA 510(k)

Karl Storz UROMAT E.A.S.I.

K-Number: K162992 · 2017-07-07

Decision Date2017-07-07
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Karl Storz UROMAT E.A.S.I. is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2017-07-07 under 510(k) 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. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K162992.

When did Karl Storz UROMAT E.A.S.I. receive FDA 510(k) clearance?

Karl Storz UROMAT E.A.S.I. received FDA 510(k) clearance on 2017-07-07, under 510(k) number K162992.

Who is the listed applicant for Karl Storz UROMAT E.A.S.I.?

The FDA 510(k) record lists Karl Storz Endoscopy America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Karl Storz Endoscopy America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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