MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001— 510(k) K010607

Clearance details

Applicant

Benlan, Inc.

Product code

Code LJH

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

2001-03-01

Decision date

2001-11-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oakville, CA

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• K162992 — Karl Storz UROMAT E.A.S.I.2017-07-07
• K070873 — AMSURE BLADDER IRRIGATION SET2007-12-19
• K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM2007-09-18
• K063700 — SPYGLASS IRRIGATION SYSTEM2007-02-08

• K131183 — MED-RX ORAL/ENTERAL SYRINGE2014-06-03
• K120375 — MED-RX PATIENT DELIVERY SET2012-06-28
• K112799 — MED-RX EXTENSION SET WITH T-CONNECTOR2011-12-23
• K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES2010-12-13
• K102073 — MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS2010-11-08

• Z-0202-2023 — MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001Class III·Terminated·Canadian Hospital Specialties·20220819

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010607.