Product code LJH
- Device name
- System, Irrigation, Urological
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162992 | Karl Storz UROMAT E.A.S.I. | Karl Storz Endoscopy America, Inc. | 2017-07-07 |
| K070873 | AMSURE BLADDER IRRIGATION SET | Amsino Intl., Inc. | 2007-12-19 |
| K071832 | MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | 2007-09-18 |
| K063700 | SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | 2007-02-08 |
| K062551 | NEXUS IRRIGATION TUBING SET | Nexus Medical, LLC | 2006-12-15 |
| K042457 | URO PRO | W.O.M. World of Medicine AG | 2004-10-25 |
| K040094 | PIGGYBACK IRRIGATING SYSTEM | Kosin Technologies, LLC | 2004-04-15 |
| K023808 | IRRIGATION SETS | International Medsurg Connection | 2003-03-10 |
| K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 | Benlan, Inc. | 2001-11-28 |
| K010122 | CONTINUOUS FLOW Y-TUBING | G.U.-Tek | 2001-06-04 |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Northgate Technologies, Inc. | 2000-08-18 |
| K990909 | MTP UROPUMP DISPOSABLE TUBING SET | Mtp Medical Technical Promotion GmbH | 1999-06-09 |
| K981615 | KSEA UROPUMP | KARL STORZ Endoscopy-America, Inc. | 1998-07-08 |
| K980808 | ENDO FMS UROLOGY | Future Medical Systems, Inc. | 1998-05-08 |
| K971982 | KARL STORZ MODEL 203020 20 EQUIMAT | KARL STORZ Endoscopy-America, Inc. | 1997-08-12 |
| K970946 | MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET | Medline Industries, Inc. | 1997-06-10 |
| K962670 | NHMC IRRIGATION TRAY | National Healthcare Mfg. Corp. | 1996-08-14 |
| K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | Baxter Healthcare Corp | 1996-05-14 |
| K943361 | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY | Northgate Technologies, Inc. | 1995-09-29 |
| K952583 | AQUISEN | Aquintel, Inc. | 1995-08-24 |
| K951569 | SURGACTIVATOR | Deschutes Medical Products, Inc. | 1995-06-06 |
| K945140 | URO-FLO | Mallinckrodt Group, Inc. | 1995-03-08 |
| K945210 | KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP | KARL STORZ Endoscopy-America, Inc. | 1995-02-07 |
| K940983 | THE KARL STORZ UROMAT(TM) | KARL STORZ Endoscopy-America, Inc. | 1994-09-20 |
| K941385 | PRO PULSE SYRINGE IRRIGATION SYSTEM | Giesy Consultants, Inc. | 1994-06-09 |
| K882295 | FILLING VOLUME OPTION | Eris Medical Technology | 1988-09-13 |
| K832040 | STERILE FLUID PRODUCING UNIT #EP550 | American Cystocope Makers, Inc. | 1983-09-29 |
| K822743 | SOLID STATE CONTINUOUS FLOW CONTROL | Widran Urological Group, Ltd. | 1982-09-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810068811046 | MONARCH™Platform, Urology | Auris Health, Inc. | 2026-05-05 |
| 10810068811053 | Monarch® Ureteroscopy Kit | Auris Health, Inc. | 2026-05-05 |
| 10704411021544 | AMSure® Cystoscopy/Bladder Irrigation Set | AMSINO INTERNATIONAL, INC. | 2026-04-10 |
| 10704411021551 | AMSure® Four Lead Bladder Irrigation Set | AMSINO INTERNATIONAL, INC. | 2026-04-10 |
| 00191506047962 | Asurys™ | BOSTON SCIENTIFIC CORPORATION | 2026-04-03 |
| 00191506023348 | Asurys™ | BOSTON SCIENTIFIC CORPORATION | 2026-04-03 |
| 40704411016107 | AMSure ® Cystoscopy/Bladder Irrigation Set | AMSINO INTERNATIONAL, INC. | 2023-04-13 |
| 40704411016091 | AMSure ® Four Lead Bladder Irrigation Set | AMSINO INTERNATIONAL, INC. | 2023-04-13 |
| 10704411016090 | AMSure ® Four Lead Bladder Irrigation Set | AMSINO INTERNATIONAL, INC. | 2023-04-13 |
| 10704411016106 | AMSure ® Cystoscopy/Bladder Irrigation Set | AMSINO INTERNATIONAL, INC. | 2023-04-13 |
| 10080196993826 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 40080196993810 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 10080196993819 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 10080196993833 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 10884389942604 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 00817183020363 | Flo-Assist II | NORTHGATE TECHNOLOGIES INC. | 2016-10-14 |
| 10884389942611 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10884389942628 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 00085412001029 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412001036 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412001050 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412001067 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412001005 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412000985 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412000978 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 04048551065273 | EQUIMAT | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 10704411005476 | AMSure® TUR/Bladder Irrigation Set Y-Type | AMSINO INTERNATIONAL, INC. | 2016-09-23 |
| 40704411005477 | AMSure® TUR/Bladder Irrigation Set Y-Type | AMSINO INTERNATIONAL, INC. | 2016-09-23 |
| 10809160060971 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 00653160177169 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-14 |