510(k) K970946
- Device
- MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
- Applicant
- MEDLINE INDUSTRIES, INC.
- 510(k) number
- K970946
- Product code
- LJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-10
- Date received
- 1997-03-14
- Regulation
- 876.5130
- Classification name
- System, Irrigation, Urological
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINE GALEA
- Address
- One Medline Pl. Mundelein IL US 60060 60060
FDA Registration Numbers#
- 3015173212
- 2029275
- 1423662
- 8040700
- 3033536319
- 3003704957
- 3015276780
- 2649614
- 2648623
- 3010202439
- 2936485
- 3002907620
- 1319639
- 1054241
- 1423625
- 1018470
- 3023460764
- 3017636737
- 3009538961
- 9611665
- 3013188547
- 3004519921
- 3011707784
- 9614434
- 1422634
- 3013764800
- 1055236
- 3017425975
- 3010419931
- 3009328501
- 3003902757
- 2953359
- 1221934
- 2020550
- 3004530184
- 1047429
- 1061124
- 3043226252
- 9614279
- 3035642068
- 3030733800
- 2320762
- 1043214
- 3011944170
- 3005099803
- 3013298431
- 3012809732
- 3007681502
- 1417592
- 2648666
- 3008850249
- 8022210
- 3013517171
- 3017961114
- 3016761372
- 3012494290
- 3006787036
- 3008824097
- 2523676
- 3008403546
- 3004194523
- 3005669815
- 3012322232
- 1030451
- 3030447506
- 1416980
- 3014579161
- 3010707607
- 3003627840
- 9610617
- 2521402
- 2030624
- 3014342096
- 3013557562
- 3010432890
- 1526711
- 9612052
Source Documents#
Other 510(k) Records For Product Code LJH #
| 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 |
Legacy Summary#
summary
FDA Review#
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