| 2026-08-05 |
K260737 |
Convatec
|
Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). |
| 2026-07-17 |
K261658 |
Wellspect AB
|
LoFric Origo Pro Coudé |
| 2026-07-07 |
K262045 |
Coloplast A.S.
|
Luja Soft |
| 2026-06-24 |
K260394 |
Hangzhou Jimushi Meditech Co., Ltd.
|
Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) |
| 2026-05-18 |
K253295 |
Hollister Incorporated
|
Coude Sleeved IC; Coude Plus Sleeved IC |
| 2026-04-24 |
K260999 |
Wellspect AB
|
LoFric Elle Pro |
| 2026-04-01 |
K252943 |
Convatec Limited
|
GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women |
| 2026-03-12 |
K260502 |
HR Healthcare
|
Liv Pre-lubricated Intermittent Catheter |
| 2026-01-29 |
K251274 |
HR Healthcare
|
EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits |
| 2026-01-02 |
K251178 |
Jamjoom Fullcare Corporation
|
Ready to use Nelaton Catheter |
| 2025-10-03 |
K251468 |
Hollister Incorporated
|
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) |
| 2025-09-26 |
K250659 |
Wellspect AB
|
LoFric Origo |
| 2025-07-01 |
K250699 |
Convatec
|
Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) |
| 2025-06-27 |
K251116 |
Coloplast Corp.
|
Luja Coudé |
| 2025-06-26 |
K243175 |
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
|
Disposable Intermittent Catheter (TPU Catheter) |
| 2025-04-17 |
K250270 |
Coloplast Corp.
|
Luja Set |
| 2024-11-26 |
K242049 |
Coloplast Corp.
|
SureCath Set |
| 2024-11-21 |
K241210 |
Coloplast Corp.
|
Luja Coude |
| 2024-07-26 |
K241028 |
Coloplast
|
Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) |
| 2024-05-03 |
K233524 |
Hollister Incorporated
|
Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) |
| 2024-01-25 |
K232665 |
Convatec
|
GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) |
| 2023-11-08 |
K230400 |
Convatec, Inc.
|
Cure Catheter Closed System; Cure Dextra Closed System |
| 2023-10-26 |
K233101 |
Coloplast Corp.
|
Luja Coude (20108 Male CH18 - large packaging) |
| 2023-08-25 |
K230165 |
Coloplast
|
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) |
| 2023-05-22 |
K220722 |
Well Lead Medical Co., Ltd.
|
PVC Hydrophilic Urethral Catheter |