Olympus
Insertion sleeve, for suprapubic overflow controller
1manufacturer
6catalogue numbers in this listing
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 | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | KOB |
| Device type | Catheter, Suprapubic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5090 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K904798 |
| Record published | 2016-09-21 |
| Record revised | 2024-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2024-05-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A2247 | Withdrawn | |
| A2248 | Withdrawn | |
| A2251 | Withdrawn | |
| A2249 | Withdrawn | |
| A2246 | Withdrawn | |
| A2250 | Withdrawn |
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 |
| S-Cath™ | Mediplus Ltd. | 7 |
| Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) | Fortune Medical Instrument Corp. | 7 |
| Mediplus | Mediplus Ltd. | 6 |
Showing 12 of 23. All products under Catheter, Suprapubic (And Accessories)
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.