Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SONOLITH I-SYS LITHOTRIPER

K-Number: K083614 · 2009-07-27

ApplicantTechnomed Medical Systems, SA
Decision Date2009-07-27
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SONOLITH I-SYS LITHOTRIPER is the device name listed in this FDA 510(k) record. The listed applicant is Technomed Medical Systems, SA. It received FDA 510(k) clearance on 2009-07-27 under 510(k) number K083614. 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 SONOLITH I-SYS LITHOTRIPER?

SONOLITH I-SYS LITHOTRIPER is a medical device that received FDA 510(k) clearance on 2009-07-27. The listed applicant is Technomed Medical Systems, SA. The 510(k) number is K083614.

When did SONOLITH I-SYS LITHOTRIPER receive FDA 510(k) clearance?

SONOLITH I-SYS LITHOTRIPER received FDA 510(k) clearance on 2009-07-27, under 510(k) number K083614.

Who is the listed applicant for SONOLITH I-SYS LITHOTRIPER?

The FDA 510(k) record lists Technomed Medical Systems, SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOLITH I-SYS LITHOTRIPER?

The FDA product code for SONOLITH I-SYS LITHOTRIPER 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

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.

↑