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)

TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)

K-Number: K050091 · 2005-03-16

ApplicantDirex Systems Corp.
Decision Date2005-03-16
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) is the device name listed in this FDA 510(k) record. The listed applicant is Direx Systems Corp.. It received FDA 510(k) clearance on 2005-03-16 under 510(k) number K050091. 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 TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)?

TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) is a medical device that received FDA 510(k) clearance on 2005-03-16. The listed applicant is Direx Systems Corp.. The 510(k) number is K050091.

When did TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) receive FDA 510(k) clearance?

TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) received FDA 510(k) clearance on 2005-03-16, under 510(k) number K050091.

Who is the listed applicant for TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)?

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

What is the FDA product code for TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)?

The FDA product code for TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) 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 Direx Systems Corp. 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.

K111947DUET MAGNAK102765PRONEXK072529TRACKPORTK071701TRACKLEAF-10K063482CROSSPLAN / ACCUSOFT-XL V.4.04K062147INTEGRA SL

View all 22 devices →

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.

↑