510(k) K852490
- Device
- URI-CATH SYSTEM
- Applicant
- GESCO INTL., INC.
- 510(k) number
- K852490
- Product code
- KNX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-05
- Date received
- 1985-06-12
- Regulation
- 876.5250
- Classification name
- Collector, Urine, (and Accessories) For Indwelling Catheter
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code KNX #
| 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 |
Legacy Summary#
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FDA Review#
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