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FDA 510(k)

STS-T LITHOTRIPTER, MODEL STS-T

K-Number: K010900 · 2001-04-05

ApplicantMedstone Intl., Inc.
Decision Date2001-04-05
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STS-T LITHOTRIPTER, MODEL STS-T is the device name listed in this FDA 510(k) record. The listed applicant is Medstone Intl., Inc.. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010900. 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 STS-T LITHOTRIPTER, MODEL STS-T?

STS-T LITHOTRIPTER, MODEL STS-T is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Medstone Intl., Inc.. The 510(k) number is K010900.

When did STS-T LITHOTRIPTER, MODEL STS-T receive FDA 510(k) clearance?

STS-T LITHOTRIPTER, MODEL STS-T received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010900.

Who is the listed applicant for STS-T LITHOTRIPTER, MODEL STS-T?

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

What is the FDA product code for STS-T LITHOTRIPTER, MODEL STS-T?

The FDA product code for STS-T LITHOTRIPTER, MODEL STS-T 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 Medstone Intl., 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.

K013620MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTIONK905278STS(TM) FLUOROSCOPIC IMAGING MODULE

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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