510(k) K945806
- Device
- SILICATH ALL SILICONE FOLEY CATHETER
- Applicant
- UNOMEDICAL SDN BHD
- 510(k) number
- K945806
- Product code
- EZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-21
- Date received
- 1994-11-28
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LIM K KANG
- Address
- Bakar Arang Industrial Estate P.O. Box 18 Sungai Petani, Kedah MY 08007 08007
FDA Registration Numbers#
- 3000247873
- 3015173212
- 3012050423
- 1423537
- 3011987967
- 3014656749
- 1423662
- 3007289408
- 3031190571
- 3010400865
- 8022978
- 3009057691
- 3015997711
- 3003537036
- 3027547323
- 3009086335
- 3016998661
- 2032112
- 3002907620
- 9616088
- 2011171
- 1018233
- 3029906222
- 1054241
- 1928237
- 3012833053
- 3015337348
- 3043051314
- 3000268902
- 1721686
- 3027301746
- 3008959444
- 3000308637
- 9610711
- 3010220595
- 3030089838
- 3000247987
- 3011707784
- 2029015
- 3014650073
- 1921846
- 3005483737
- 3003903031
- 9611590
- 1055236
- 3007798534
- 3004111573
- 1825146
- 3027553380
- 3013369910
- 3008806809
- 9611712
- 3030970103
- 3003814961
- 1649518
- 3004070478
- 1820334
- 9612030
- 1061124
- 2432320
- 1526534
- 3005012805
- 3003965134
- 3021468326
- 3006621386
- 3005515211
- 3010173425
- 3016904853
- 1043214
- 2320762
- 3003477135
- 3014637079
- 1058397
- 3016738724
- 3012104670
- 3022518300
- 3013298431
- 3016618143
- 1417592
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EZL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026-01-20 |
| 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 |
Legacy Summary#
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FDA Review#
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