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FDA 510(k)

MODULITH SLK LITHOTRIPTER

K-Number: K011700 · 2002-08-16

ApplicantKarl Storz Endoscopy
Decision Date2002-08-16
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODULITH SLK LITHOTRIPTER is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 2002-08-16 under 510(k) number K011700. 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 SLK LITHOTRIPTER?

MODULITH SLK LITHOTRIPTER is a medical device that received FDA 510(k) clearance on 2002-08-16. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K011700.

When did MODULITH SLK LITHOTRIPTER receive FDA 510(k) clearance?

MODULITH SLK LITHOTRIPTER received FDA 510(k) clearance on 2002-08-16, under 510(k) number K011700.

Who is the listed applicant for MODULITH SLK LITHOTRIPTER?

The FDA 510(k) record lists Karl Storz Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODULITH SLK LITHOTRIPTER?

The FDA product code for MODULITH SLK LITHOTRIPTER is LNS.

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Other records listing Karl Storz Endoscopy as applicant

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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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