Panels › Gastroenterology, Urology › Product code LJH · Class 2
System, Irrigation, Urological
Regulation 876.5130
2510(k)s in 12 months (30 all time)
0recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in LJH
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 5 | 0 |
| Baxter Healthcare Corp | 1 | 3 |
| Hospira Inc. | 0 | 2 |
| Medical Scientific, Inc. | 2 | 0 |
| Northgate Technologies, Inc. | 2 | 0 |
| American Cystocope Makers, Inc. | 1 | 0 |
| Amsino Intl., Inc. | 1 | 0 |
| Aquintel, Inc. | 1 | 0 |
| B.Braun Medical, Inc. | 1 | 0 |
| Benlan, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2026 | K261670 | Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Ty Poly Medicure Limited, IN | LJH |
| Sep 10, 2026 | K254111 | Irrigation/Urology Sets B.Braun Medical, Inc. | LJH |
| Jul 7, 2017 | K162992 | Karl Storz UROMAT E.A.S.I. Karl Storz Endoscopy America, Inc. | LJH |
| Dec 19, 2007 | K070873 | AMSURE BLADDER IRRIGATION SET Amsino Intl., Inc. | LJH |
| Sep 18, 2007 | K071832 | MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM Medical Scientific, Inc. | LJH |
| Feb 8, 2007 | K063700 | SPYGLASS IRRIGATION SYSTEM Medical Scientific, Inc. | LJH |
| Dec 15, 2006 | K062551 | NEXUS IRRIGATION TUBING SET Nexus Medical, LLC | LJH |
| Oct 25, 2004 | K042457 | URO PRO W.O.M. World of Medicine AG | LJH |
| Apr 15, 2004 | K040094 | PIGGYBACK IRRIGATING SYSTEM Kosin Technologies, LLC | LJH |
| Mar 10, 2003 | K023808 | IRRIGATION SETS International Medsurg Connection | LJH |
| Nov 28, 2001 | K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 Benlan, Inc., CA | LJH |
| Jun 4, 2001 | K010122 | CONTINUOUS FLOW Y-TUBING G.U.-Tek | LJH |
| Aug 18, 2000 | K001325 | FLO ASSISTANT, MODEL 4-250-00 Northgate Technologies, Inc. | LJH |
| Jun 9, 1999 | K990909 | MTP UROPUMP DISPOSABLE TUBING SET Mtp Medical Technical Promotion GmbH | LJH |
| Jul 8, 1998 | K981615 | KSEA UROPUMP KARL STORZ Endoscopy-America, Inc. | LJH |
| May 8, 1998 | K980808 | ENDO FMS UROLOGY Future Medical Systems, Inc. | LJH |
| Aug 12, 1997 | K971982 | KARL STORZ MODEL 203020 20 EQUIMAT KARL STORZ Endoscopy-America, Inc. | LJH |
| Jun 10, 1997 | K970946 | MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET Medline Industries, Inc. | LJH |
| Aug 14, 1996 | K962670 | NHMC IRRIGATION TRAY National Healthcare Mfg. Corp., CA | LJH |
| May 14, 1996 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS Baxter Healthcare Corp | LJH |
| Sep 29, 1995 | K943361 | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY Northgate Technologies, Inc. | LJH |
| Aug 24, 1995 | K952583 | AQUISEN Aquintel, Inc. | LJH |
| Jun 6, 1995 | K951569 | SURGACTIVATOR Deschutes Medical Products, Inc. | LJH |
| Mar 8, 1995 | K945140 | URO-FLO Mallinckrodt Group, Inc. | LJH |
| Feb 7, 1995 | K945210 | KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP KARL STORZ Endoscopy-America, Inc. | LJH |
| Sep 20, 1994 | K940983 | THE KARL STORZ UROMAT(TM) KARL STORZ Endoscopy-America, Inc. | LJH |
| Jun 9, 1994 | K941385 | PRO PULSE SYRINGE IRRIGATION SYSTEM Giesy Consultants, Inc. | LJH |
| Sep 13, 1988 | K882295 | FILLING VOLUME OPTION Eris Medical Technology | LJH |
| Sep 29, 1983 | K832040 | STERILE FLUID PRODUCING UNIT #EP550 American Cystocope Makers, Inc. | LJH |
| Sep 24, 1982 | K822743 | SOLID STATE CONTINUOUS FLOW CONTROL Widran Urological Group, Ltd. | LJH |
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