S-Cath™
S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 16Fr. 10cc, 42cm
1manufacturer
7catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Mediplus Ltd., United Kingdom |
|---|---|
| FDA product code | KOB |
| Device type | Catheter, Suprapubic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5090 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K132890 |
| Record published | 2015-10-17 |
| Record revised | 2024-05-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 5 |
| Sizes | Length 42 cm; catheter gauge 12 to 16 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5756 | Length 42.0 cm | In distribution |
| 5759 | Length 42.0 cm | In distribution |
| 5759-L | Length 42.0 cm | In distribution |
| 5757 | Catheter Gauge 14.0 Fr | In distribution |
| 5760 | Length 42.0 cm | In distribution |
| 5753 | Length 42.0 cm | In distribution |
| 5754 | Catheter Gauge 14.0 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MiniSPC Button | Applied Medical Technology, Inc. | 284 |
| Malecot | Cook Incorporated | 39 |
| Cook | Cook Incorporated | 35 |
| Stamey | Cook Incorporated | 16 |
| Silicone Supra-Pubic Catheter (Ordinary Balloon) | Fortune Medical Instrument Corp. | 10 |
| Rutner | Cook Incorporated | 9 |
| Silicone Supra-Pubic Catheter (Integrated Balloon) | Fortune Medical Instrument Corp. | 8 |
| Cook-Cope Loop | Cook Incorporated | 8 |
| Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) | Fortune Medical Instrument Corp. | 7 |
| Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) | Fortune Medical Instrument Corp. | 7 |
| Mediplus | Mediplus Ltd. | 6 |
| AMT MiniSPC Drainage Set | Applied Medical Technology, Inc. | 6 |
Showing 12 of 23. All products under Catheter, Suprapubic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132890 | 2014-01-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.