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FDA 510(k)

Delta III Lithotripter

K-Number: K201074 · 2020-09-03

ApplicantDornier Medtech America, Inc.
Decision Date2020-09-03
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Delta III Lithotripter is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2020-09-03 under 510(k) 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. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K201074.

When did Delta III Lithotripter receive FDA 510(k) clearance?

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

Who is the listed applicant for Delta III Lithotripter?

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

What is the FDA product code for Delta III Lithotripter?

The FDA product code for Delta III Lithotripter is LNS.

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Related Devices (Code: LNS)

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.

K261086Break WaveSonomotion, Inc.K252913Break WaveSonomotion, Inc.K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.K221903Delta III ProDornier Medtech America, Inc.K213772LM-9300 Plus LithotripterLite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy America

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.

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