Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001
FDA 510(k) K010607 · Benlan, Inc.
510(k) numberK010607
Submission
- Device name
- Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001
- Applicant
- Benlan, Inc.
Oakville, CA - Received
- March 1, 2001
- Decision date
- November 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJH – System, Irrigation, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LJH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254111 | Irrigation/Urology SetsLJH · Traditional | B.Braun Medical, Inc. | 09/10/2026SE |
| K162992 | Karl Storz UROMAT E.A.S.I.LJH · Traditional | Karl Storz Endoscopy America, Inc. | 07/07/2017SE |
| K070873 | Amsure Bladder Irrigation SetLJH · Traditional | Amsino Intl., Inc. | 12/19/2007SE |
| K071832 | Modifcation to: Spyglass Irrigation SystemLJH · Special | Medical Scientific, Inc. | 09/18/2007SE |
| K063700 | Spyglass Irrigation SystemLJH · Traditional | Medical Scientific, Inc. | 02/08/2007SE |
| K062551 | Nexus Irrigation Tubing SetLJH · Traditional | Nexus Medical, LLC | 12/15/2006SE |
| K042457 | Uro ProLJH · Traditional | W.O.M. World of Medicine AG | 10/25/2004SE |
| K040094 | Piggyback Irrigating SystemLJH · Abbreviated | Kosin Technologies, LLC | 04/15/2004SE |
| K023808 | Irrigation SetsLJH · Traditional | International Medsurg Connection | 03/10/2003SE |
| K010122 | Continuous Flow Y-TubingLJH · Traditional | G.U.-Tek | 06/04/2001SE |
More from G.U.-Tek
| 510(k) | Device | Decision |
|---|---|---|
| K131183 | Med-Rx Oral/Enteral SyringeKNT · Traditional | 06/03/2014SE |
| K120375 | Med-Rx Patient Delivery SetFPA · Traditional | 06/28/2012SE |
| K112799 | Med-Rx Extension Set with T-ConnectorFPA · Traditional | 12/23/2011SE |
| K100700 | Med-Rx Pediatric Feeding Tubes and AccessoriesFPD · Traditional | 12/13/2010SE |
| K102073 | Med-Rx Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TSFPA · Traditional | 11/08/2010SE |
| K990777 | Med-Rx Extension SetsFPA · Traditional | 08/25/1999SE |
Questions and answers
When was Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001 cleared by the FDA?
Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001 (K010607) received a 510(k) decision of Substantially Equivalent on November 28, 2001, 272 days after the submission was received.
What is the product code of K010607?
The FDA product code is LJH – System, Irrigation, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.