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FDA 510(k)

GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

K-Number: K042427 · 2004-12-03

ApplicantGenemed, Inc.
Decision Date2004-12-03
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER is the device name listed in this FDA 510(k) record. The listed applicant is Genemed, Inc.. It received FDA 510(k) clearance on 2004-12-03 under 510(k) number K042427. 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 GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER?

GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER is a medical device that received FDA 510(k) clearance on 2004-12-03. The listed applicant is Genemed, Inc.. The 510(k) number is K042427.

When did GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER receive FDA 510(k) clearance?

GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER received FDA 510(k) clearance on 2004-12-03, under 510(k) number K042427.

Who is the listed applicant for GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER?

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

What is the FDA product code for GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER?

The FDA product code for GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER is LNS.

Related Clinical Trials

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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Other records listing Genemed, 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.

K943479GENEMED YAG 1000 MEDICAL LASER

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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