510(k) K252537
- Device
- Rusch SoftSimplastic Foley Catheters
- Applicant
- Teleflex Medical Sdn. Bhd.
- 510(k) number
- K252537
- Product code
- EZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-20
- Date received
- 2025-08-12
- Regulation
- 876.5130
- Classification name
- Catheter, Retention Type, Balloon
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Yuvaanesswary Nallappan
- Address
- Lot Pt. 2577, Jalan Perusahaan 4 Kamunting MY 34000 34000
FDA Registration Numbers
- 1423662
- 1825146
- 3014637079
- 3022516937
- 1061124
- 3003903031
- 3012833053
- 3012649202
- 8040607
- 3022518300
- 3006621386
- 8043983
- 3015997711
- 3005012805
- 2648727
- 3011383638
- 3001124136
- 3013557562
- 3010131137
- 3011987967
- 1423537
- 1721676
- 1820334
- 3013298431
- 3000247873
- 3043051314
- 1018233
- 3010580321
- 3005515211
- 3003537036
- 3014656749
- 3016998661
- 9611590
- 8030107
- 1043214
- 3002907620
- 1055236
- 3008959444
- 3012421607
- 3005669815
- 1649518
- 1058584
- 3015176887
- 3016618143
- 3015173212
- 3014650073
- 3006787036
- 3030089838
- 3016738724
- 3038139564
- 3031175043
- 8041005
- 2029015
- 3014579161
- 3011252788
- 1417592
- 1928237
- 1058397
- 1526534
- 3003965134
- 3027553380
- 3003477135
- 3007289408
- 3015142802
- 1650927
- 3030970103
- 3005609751
- 2030624
- 3005941719
- 2320762
- 1921846
- 3007156625
- 3008559295
- 9611712
- 2432320
- 8040412
- 2032112
- 3016761372
- 3010621964
Source Documents
Other 510(k) Records For Product Code EZL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. | 2025-06-16 |
| K241424 | InnoCare Specialty Foley Catheter | Innocare Urologics, LLC | 2024-09-18 |
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024-08-01 |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2024-04-17 |
| K233411 | Folysil Silicone Catheter | Coloplast Corp. | 2024-04-15 |
| K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | 2024-01-23 |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023-07-27 |
| K231101 | Flume Catheter | Flume Catheter Company, Ltd. | 2023-06-29 |
| K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F | Potrero Medical, Inc. | 2023-01-13 |
| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | 2022-12-01 |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | 2022-07-01 |
| K212151 | FLUME catheter | The Flume Catheter Company, Ltd. | 2021-11-03 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | 2021-04-08 |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020-12-30 |
| K202698 | Prefilled Syringe | Hangzhou Primecare Medical Co., Ltd. | 2020-12-15 |