FDA 510(k)

Delta III Lithotripter

K-Number: K201074 · 2020-09-03

Decision Date2020-09-03

Product CodeLNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Delta III Lithotripter is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2020-09-03 under approval number K201074. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Delta III Lithotripter?

Delta III Lithotripter is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K201074.

When was Delta III Lithotripter approved by the FDA?

Delta III Lithotripter received FDA 510(k) clearance on 2020-09-03, under approval number K201074.

What company makes Delta III Lithotripter?

Delta III Lithotripter is manufactured by Dornier Medtech America, Inc..

What is the FDA product code for Delta III Lithotripter?

The FDA product code for Delta III Lithotripter is LNS.

Other Devices by Dornier Medtech America, Inc.

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Related Devices (Code: LNS)

K172084Delta III LithotripterDornier Medtech America, Inc. K170122Delta III LithotripterDornier Medtech America K201001Modulith SLX-F2Karl Storz Endoscopy America K221903Delta III ProDornier Medtech America, Inc. K213772LM-9300 Plus LithotripterLite-Med, Inc. K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.

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.