Identity
- Trade Name
- T-SPeC FDA UDI
- Generic Name
- Suprapubic drainage catheter FDA UDI
- Device Name
- Transurethral Suprapubic endo-Cystostomy FDA UDI
- Model / Reference
- T7 FDA UDI
- Description
- Transurethral Suprapubic endo-Cystostomy FDA UDI
Identifiers
- Catalog Number
- 107 FDA UDI
- Primary DI / UDI-DI
- 00856995003003 FDA UDI
- 510(k) Number
- K120127 FDA UDI
- FDA Product Code
- FEX FDA UDIKOB FDA UDI
- GMDN Term
- Suprapubic drainage catheter FDA UDI
Classification
- Device Class
- Class I 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
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 18 French FDA UDI
Category: Suprapubic drainage catheter
T-SPeC by Swan Valley Medical, Incorporated — Class I — 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
K120127 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Swan Valley Medical, Incorporated
Sources (1)
- FDA UDI 6252f336-944a-469f-b8aa-3535d500e4c5 37 fields · synced May 31, 2026