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FDA 510(k)

MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI

K-Number: K010340 · 2001-02-13

ApplicantKarl Storz Lithotripsy-America, Inc.
Decision Date2001-02-13
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Lithotripsy-America, Inc.. It received FDA 510(k) clearance on 2001-02-13 under 510(k) number K010340. 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 MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI?

MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI is a medical device that received FDA 510(k) clearance on 2001-02-13. The listed applicant is Karl Storz Lithotripsy-America, Inc.. The 510(k) number is K010340.

When did MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI receive FDA 510(k) clearance?

MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI received FDA 510(k) clearance on 2001-02-13, under 510(k) number K010340.

Who is the listed applicant for MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI?

The FDA 510(k) record lists Karl Storz Lithotripsy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI?

The FDA product code for MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI is LNS.

Related Clinical Trials

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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

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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