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FDA 510(k)

DORNIER LITHOTRIPTER 140(DOLI 140)

K-Number: K011773 · 2001-06-22

ApplicantDornier
Decision Date2001-06-22
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DORNIER LITHOTRIPTER 140(DOLI 140) is the device name listed in this FDA 510(k) record. The listed applicant is Dornier. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K011773. 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 DORNIER LITHOTRIPTER 140(DOLI 140)?

DORNIER LITHOTRIPTER 140(DOLI 140) is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is Dornier. The 510(k) number is K011773.

When did DORNIER LITHOTRIPTER 140(DOLI 140) receive FDA 510(k) clearance?

DORNIER LITHOTRIPTER 140(DOLI 140) received FDA 510(k) clearance on 2001-06-22, under 510(k) number K011773.

Who is the listed applicant for DORNIER LITHOTRIPTER 140(DOLI 140)?

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

What is the FDA product code for DORNIER LITHOTRIPTER 140(DOLI 140)?

The FDA product code for DORNIER LITHOTRIPTER 140(DOLI 140) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dornier 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.

K011873DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)K984349DORNIER MEDILAS R

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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