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FDA 510(k)

DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER

K-Number: K013471 · 2002-04-29

ApplicantE.S.W.L. Products, Inc.
Decision Date2002-04-29
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER is the device name listed in this FDA 510(k) record. The listed applicant is E.S.W.L. Products, Inc.. It received FDA 510(k) clearance on 2002-04-29 under 510(k) number K013471. 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 2000 SERIES EXTRACORPOREAL LITHOTRIPTER?

DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER is a medical device that received FDA 510(k) clearance on 2002-04-29. The listed applicant is E.S.W.L. Products, Inc.. The 510(k) number is K013471.

When did DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER receive FDA 510(k) clearance?

DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER received FDA 510(k) clearance on 2002-04-29, under 510(k) number K013471.

Who is the listed applicant for DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER?

The FDA 510(k) record lists E.S.W.L. Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER?

The FDA product code for DELTA 2000 SERIES EXTRACORPOREAL 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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