510(k) K062444
- Device
- HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT
- Applicant
- OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S.
- 510(k) number
- K062444
- Product code
- EZD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-22
- Date received
- 2006-08-21
- Regulation
- 876.5130
- Classification name
- Catheter, Straight
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES H KYPER
- Address
- 208 Barrington Overlook Durham NC US 27703 27703
FDA Registration Numbers#
- 3038139564
- 2320961
- 1018233
- 3011020307
- 9612030
- 1061124
- 3005562917
- 3005515211
- 3008806809
- 1000317571
- 3023329815
- 3010400865
- 3006536657
- 3015131144
- 1054241
- 3006553489
- 3005690789
- 8043792
- 9617594
- 3006673317
- 3008102042
- 2024024
- 3011987967
- 3005669815
- 1928237
- 2030598
- 9610694
- 3008772421
- 9613662
- 3007697249
- 1647149
- 1043214
- 3005945907
- 3031571464
- 3005778470
- 3006891611
- 3014498861
- 3018116884
- 9616067
- 3006405073
- 3015176887
- 3016863553
- 3020976354
- 1713468
- 1921846
- 3005012805
- 3008262278
- 1055236
- 3008502431
- 3007007790
- 3016675012
- 3003974574
- 3023174629
- 3009746061
- 3002807314
- 1417592
- 3014579161
- 3016761372
- 3011707784
- 3014421917
- 3010288357
- 9611590
- 2032112
- 3006082230
- 1423537
- 2029015
- 1480288
- 3016171914
- 3009504230
- 3003717263
- 3002993863
- 3003903031
- 3006606901
- 3011270181
- 3008729910
- 3015142802
- 3006430057
- 3009632672
- 3005941719
- 9616668
Source Documents#
Other 510(k) Records For Product Code EZD #
| 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); 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) | 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 |
Legacy Summary#
summary
FDA Review#
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