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)

MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001

K-Number: K010607 · 2001-11-28

ApplicantBenlan, Inc.
Decision Date2001-11-28
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 is the device name listed in this FDA 510(k) record. The listed applicant is Benlan, Inc.. It received FDA 510(k) clearance on 2001-11-28 under 510(k) number K010607. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001?

MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 is a medical device that received FDA 510(k) clearance on 2001-11-28. The listed applicant is Benlan, Inc.. The 510(k) number is K010607.

When did MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 receive FDA 510(k) clearance?

MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 received FDA 510(k) clearance on 2001-11-28, under 510(k) number K010607.

Who is the listed applicant for MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001?

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

What is the FDA product code for MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001?

The FDA product code for MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 is LJH.

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 Benlan, Inc. 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.

K120375MED-RX PATIENT DELIVERY SETK112799MED-RX EXTENSION SET WITH T-CONNECTORK100700MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESK102073MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TSK990777MED-RX EXTENSION SETS

Related Devices (Code: LJH)

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.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC

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.

↑