Product code KNX
- Device name
- Collector, Urine, (And Accessories) For Indwelling Catheter
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5250
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110518 | IBAG | Future Path Medical, LLC | 2011-06-24 |
| K973364 | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG | Maersk Medical A/S | 1998-03-17 |
| K972887 | MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG | Medline Industries, Inc. | 1997-12-11 |
| K971271 | BESECURE EXTERNAL URINARY COLLECTION SYSTEM | Urology Research Intl., Inc. | 1997-08-18 |
| K971929 | AMSINO URINARY LEG BAG | Amsino Intl., Inc. | 1997-08-06 |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | Welcon, Inc. | 1997-07-29 |
| K964690 | LIBERTY VALVE | Cleveland Medical Devices, Inc. | 1997-03-21 |
| K964745 | AMSINO URINARY DRAINAGE BAG | Amsino Intl., Inc. | 1997-03-18 |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | Customed, Inc. | 1996-10-04 |
| K960949 | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 | Bristol-Myers Squibb | 1996-04-19 |
| K952208 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-08-15 |
| K944377 | ORION'S URINARY DRAINAGE SET | Regulatory & Marketing Services, Inc. | 1994-12-06 |
| K944236 | NEEDLELESS URINE SAMPLING PORT | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-11-16 |
| K940206 | BARD URINE COLLECTION PRODUCTS MODIFICATION | C.R. Bard, Inc. | 1994-09-16 |
| K941447 | SIMPLA S4, S5, S7 | Simpla Plastics , Ltd. | 1994-07-18 |
| K935557 | URINARY DRAINAGE BAG | Puritas Health Care, Inc. | 1994-03-07 |
| K931459 | KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-06-14 |
| K925067 | SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG | Simport Plastics, Ltd. | 1993-06-10 |
| K926570 | HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878 | Hollister, Inc. | 1993-05-21 |
| K921024 | URO-TOTE LEG BAG | Neotech Products, Inc. | 1992-09-02 |
| K913142 | BODEN WHEELCHAIR DRAINAGE SYSTEM | Mno Medical Products | 1991-09-23 |
| K913223 | STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES | Medical Device Inspection Co., Inc. | 1991-09-04 |
| K901320 | ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG | Ep Medical, Inc. | 1991-01-25 |
| K902417 | BAG, URINE | Gainor Medical Europe, Ltd. | 1990-07-16 |
| K896688 | URINE COLLECTOR LEG BAG | Medline Industries, Inc. | 1990-05-02 |
| K895168 | URO-BAGGIE | Cwt Workshop | 1990-03-22 |
| K896727 | 4 SURE URINARY DRAIN BAG | The Boston & Pacific Co., Inc. | 1990-02-20 |
| K896579 | GOOSEN URINARY DRAINAGE SYSTEM | Goosen Enterprises, Inc. | 1990-02-15 |
| K895957 | L.T.C. 1000 URINARY DRAINAGE BAG | Intl. Medical Marketing, Inc. | 1989-10-24 |
| K892437 | KENDALL KENGUARD URINARY LEG BAGS | The Kendal Co. | 1989-06-23 |
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| 10192253031126 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028560 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028546 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028539 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028522 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028461 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027938 | Dover | Cardinal Health 200, LLC | 2024-11-04 |
| 10192253028492 | Dover | Cardinal Health 200, LLC | 2024-11-04 |
| 10192253028287 | Dover | Cardinal Health 200, LLC | 2024-11-04 |
| 10192253028195 | Dover | Cardinal Health 200, LLC | 2024-10-14 |
| 10192253028201 | Dover | Cardinal Health 200, LLC | 2024-10-14 |
| 10192253028263 | Dover | Cardinal Health 200, LLC | 2024-10-14 |
| 10192253028386 | Dover | Cardinal Health 200, LLC | 2024-10-14 |
| 10080196004355 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 10080196990177 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 10080196990160 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 10080196840922 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 10080196828685 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 10080196030873 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196990337 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196446018 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196836062 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196839193 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196840779 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196840786 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196990320 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196993406 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |