Product code EZD
- Device name
- Catheter, Straight
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | Hollister Incorporated | 2026-05-18 |
| K260999 | LoFric Elle Pro | Wellspect AB | 2026-04-24 |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Convatec Limited | 2026-04-01 |
| K260502 | Liv Pre-lubricated Intermittent Catheter | HR Healthcare | 2026-03-12 |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | HR Healthcare | 2026-01-29 |
| K251178 | Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation | 2026-01-02 |
| K251468 | 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) | Hollister Incorporated | 2025-10-03 |
| K250659 | LoFric Origo | Wellspect AB | 2025-09-26 |
| K250699 | 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); ... | Convatec | 2025-07-01 |
| K251116 | Luja Coudé | Coloplast Corp. | 2025-06-27 |
| K243175 | Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2025-06-26 |
| K250270 | Luja Set | Coloplast Corp. | 2025-04-17 |
| K242049 | SureCath Set | Coloplast Corp. | 2024-11-26 |
| K241210 | Luja Coude | Coloplast Corp. | 2024-11-21 |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | Coloplast | 2024-07-26 |
| K233524 | 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) | Hollister Incorporated | 2024-05-03 |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | Convatec | 2024-01-25 |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. | 2023-11-08 |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. | 2023-10-26 |
| K230165 | 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 (Pocke... | Coloplast | 2023-08-25 |
| K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 2023-05-22 |
| K223756 | SimPro™ Now, GentleCath™ Hydrophilic | Dentsply Sirona | 2023-05-04 |
| K222677 | Intermittent nelaton catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2023-04-05 |
| K220667 | Sleeved IC | Hollister Incorporated | 2022-12-08 |
| K212567 | PVC Hydrophilic Urethral Catheter | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2022-12-07 |
| K221401 | Self-Cath and Self-Cath Plus | Coloplast | 2022-12-02 |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | Convatec, Inc. | 2022-11-17 |
| K222059 | SpeediCath Flex Set | Coloplast | 2022-09-21 |
| K213575 | Female IC (Not Finalized) | Hollister Incorporated | 2022-09-13 |
| K212430 | BONREE Nelaton Catheter | Bonree Medical Co., Ltd. | 2022-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08697749683582 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749684633 | hi-slip® plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749684626 | hi-slip® plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749684619 | hi-slip® plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749684602 | hi-slip® plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749684596 | hi-slip® plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749684589 | hi-slip® plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749684572 | hi-slip® plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683650 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683643 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683636 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683629 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683612 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683605 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683599 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683438 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683575 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683568 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683551 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683544 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683537 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683520 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683513 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683506 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683490 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683483 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683476 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683469 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683452 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |
| 08697749683445 | hi-slip® full plus | OASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETI | 2016-09-23 |