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FDA 510(k)

TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

K-Number: K042561 · 2004-10-12

ApplicantFmd, LLC
Decision Date2004-10-12
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER is the device name listed in this FDA 510(k) record. The listed applicant is Fmd, LLC. It received FDA 510(k) clearance on 2004-10-12 under 510(k) number K042561. 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 TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER?

TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER is a medical device that received FDA 510(k) clearance on 2004-10-12. The listed applicant is Fmd, LLC. The 510(k) number is K042561.

When did TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER receive FDA 510(k) clearance?

TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER received FDA 510(k) clearance on 2004-10-12, under 510(k) number K042561.

Who is the listed applicant for TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER?

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

What is the FDA product code for TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER?

The FDA product code for TWINHEADS TH-103 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 Fmd, LLC 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.

K030346TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

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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