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FDA 510(k)

EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER

K-Number: K132672 · 2013-09-23

ApplicantDornier Medtech America
Decision Date2013-09-23
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America. It received FDA 510(k) clearance on 2013-09-23 under 510(k) number K132672. 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 EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER?

EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER is a medical device that received FDA 510(k) clearance on 2013-09-23. The listed applicant is Dornier Medtech America. The 510(k) number is K132672.

When did EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER receive FDA 510(k) clearance?

EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER received FDA 510(k) clearance on 2013-09-23, under 510(k) number K132672.

Who is the listed applicant for EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER?

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

What is the FDA product code for EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER?

The FDA product code for EXTRA CORPOREAL SHOCKWAVE 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 Dornier Medtech America 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.

K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250K233380TRIDENT Mobile Fluoroscopy SystemK180350Dornier Medilas H Solvo 35 LaserK170122Delta III 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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