Identity
- Trade Name
- S-Cath™ FDA UDI
- Generic Name
- Suprapubic drainage catheter FDA UDI
- Device Name
- S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 14Fr. 10cc, 42cm FDA UDI
- Model / Reference
- 5754 FDA UDI
- Description
- S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 14Fr. 10cc, 42cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055140702265 FDA UDI
- 510(k) Number
- K132890 FDA UDI
- FDA Product Code
- KOB FDA UDI
- GMDN Term
- Suprapubic drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5090 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 14.0 French FDA UDILength — 42.0 Centimeter FDA UDI
Category: Suprapubic drainage catheter
S-Cath™ by Mediplus , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suprapubic drainage catheter.
- MiniSPC Button — Applied Medical Technology, Inc. · Class II
- Bardex® Pezzer Model Drain — C. R. Bard, Inc. · Class II
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- MiniSPC Button — Applied Medical Technology, Inc. · Class II
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- MiniSPC Button — Applied Medical Technology, Inc. · Class II
- MiniSPC Button — Applied Medical Technology, Inc. · Class II
Cleared under the same submission
K132890 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mediplus , Ltd.
Sources (1)
- FDA UDI 9d75d010-d467-48ba-b055-8dfb83e1552d 36 fields · synced Jun 8, 2026