KNX — Collector, Urine, (And Accessories) For Indwelling Catheter Class II
FDA product code KNX covers "Collector, Urine, (And Accessories) For Indwelling Catheter", a Class II medical device regulated under 21 CFR 876.5250. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KNX
- Device Class
- Class II
- Regulation Number
- 876.5250
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110518 | future path medical | IBAG | June 24, 2011 |
| K973364 | maersk medical | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG | March 17, 1998 |
| K972887 | medline industries | MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG | December 11, 1997 |
| K971271 | urology research intl | BESECURE EXTERNAL URINARY COLLECTION SYSTEM | August 18, 1997 |
| K971929 | amsino intl | AMSINO URINARY LEG BAG | August 6, 1997 |
| K971764 | welcon | WELCON HUE-VU URINARY DRAINAGE BAG | July 29, 1997 |
| K964690 | cleveland medical devices | LIBERTY VALVE | March 21, 1997 |
| K964745 | amsino intl | AMSINO URINARY DRAINAGE BAG | March 18, 1997 |
| K962652 | customed | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | October 4, 1996 |
| K960949 | bristol-myers squibb | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 | April 19, 1996 |
| K952208 | convatec, a division of e.r. squibb and sons | PROSYS LEG BAG | August 15, 1995 |
| K944377 | regulatory and marketing services | ORION'S URINARY DRAINAGE SET | December 6, 1994 |
| K944236 | kendall healthcare products co. div.of tyco health | NEEDLELESS URINE SAMPLING PORT | November 16, 1994 |
| K940206 | c.r. bard | BARD URINE COLLECTION PRODUCTS MODIFICATION | September 16, 1994 |
| K941447 | simpla plastics | SIMPLA S4, S5, S7 | July 18, 1994 |
| K935557 | puritas health care | URINARY DRAINAGE BAG | March 7, 1994 |
| K931459 | kendall healthcare products co. div.of tyco health | KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER | June 14, 1993 |
| K925067 | simport plastics | SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG | June 10, 1993 |
| K926570 | hollister | HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878 | May 21, 1993 |
| K921024 | neotech products | URO-TOTE LEG BAG | September 2, 1992 |