MiniSPC Button
14F x 10.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set, MDR
1manufacturer
284catalogue 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 | Applied Medical Technology, Inc., United States |
|---|---|
| FDA product code | KOB |
| Device type | Catheter, Suprapubic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5090 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K240514 |
| Record published | 2025-01-24 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Catheter gauge 12 to 24 Fr; length 0.8 to 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPC-1610-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1835-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1623-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1425-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1412-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1423-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-2015-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1620-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1425-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-14100-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1830-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1835-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1844-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2060-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1410-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1844-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1415-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1825-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1420-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-2440-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1610-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1815-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1460-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-2417-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1650-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1227-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1635-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-2044-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1823-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1627-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1235-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1455-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1215-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1440-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1850-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2025-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1620-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1612-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1435-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1412-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1423-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1844-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1644-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1644-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1640-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1612-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1810-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1412-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1640-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-2040-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1627-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1655-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1470-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1410-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-2027-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1810-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1435-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1220-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1465-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1625-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1223-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-2450-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-2415-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1815-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2017-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-2020-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1465-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1625-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1217-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1217-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1427-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-2423-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-1827-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1817-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1617-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1820-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1825-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1635-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1450-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-2435-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1860-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1860-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-2027-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1855-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1240-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1625-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1444-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1650-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-2010-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1220-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1840-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2030-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-2012-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-2023-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1215-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1615-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1635-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1223-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-2023-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1844-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1435-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1820-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2440-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-2012-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1480-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1480-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1830-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1230-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-2060-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-14100-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1840-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2420-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-1655-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1412-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1227-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1623-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-2017-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-2035-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1810-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1430-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1410-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1812-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1835-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1612-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1817-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1415-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1850-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1655-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-2415-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-1420-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1812-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1630-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1427-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1823-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1855-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1460-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1208-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1820-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1660-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1490-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1444-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-2025-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1610-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1627-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1480-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1815-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1430-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1420-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1444-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1825-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-2035-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1480-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1408-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1827-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1423-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1817-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-14100-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-2420-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1615-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1620-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-2444-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-14100-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1635-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-2455-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1860-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2040-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1627-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-2455-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-2425-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-1430-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1444-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-2427-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-2050-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1623-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-2015-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1812-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2460-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-1423-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1612-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1640-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1830-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1815-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1408-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-2055-12 | Catheter Gauge 20 Fr | In distribution |
| SPC-1630-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1415-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1630-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1208-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1455-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1840-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-2444-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-1240-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1617-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1850-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1235-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1650-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-2450-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1212-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1455-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-2430-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1817-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1427-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1430-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1650-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-2425-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1408-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1440-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1855-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1470-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-2055-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1840-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1440-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1617-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1660-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1490-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1415-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1470-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1440-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1644-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1820-24 | Catheter Gauge 18 Fr | In distribution |
| SPC-1490-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1425-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1465-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1460-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1660-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1620-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-2435-12 | Catheter Gauge 24 Fr | In distribution |
| SPC-1823-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-2460-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1825-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1490-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1425-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1810-12 | Catheter Gauge 18 Fr | In distribution |
| SPC-1660-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1455-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1417-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-2423-24 | Catheter Gauge 24 Fr | In distribution |
| SPC-1417-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1230-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1435-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1615-24 | Catheter Gauge 16 Fr | In distribution |
| SPC-1615-12 | Catheter Gauge 16 Fr | In distribution |
| SPC-1465-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-2020-24 | Catheter Gauge 20 Fr | In distribution |
| SPC-1210-24 | Catheter Gauge 12 Fr | In distribution |
| SPC-1470-24 | Catheter Gauge 14 Fr | In distribution |
| SPC-1210-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1450-12 | Catheter Gauge 14 Fr | In distribution |
| SPC-1225-12 | Catheter Gauge 12 Fr | In distribution |
| SPC-1623-12 | Catheter Gauge 16 Fr | In distribution |
Showing 250 of 284 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K240514 | 2024-11-01 |
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.