EndoVive Button Right Angle Feeding Set
Low Profile Button Continuous Feeding Set
25manufacturers in China registered for this device type
2catalogue numbers in this listing
10510(k) clearances naming this product code
17recalls on this code
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2024-12-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00580240 | 8.0 mm Diameter | In distribution |
| M00580180 | 6.0 mm Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| NutraGlide Nasal Feeding Tube | Applied Medical Technology, Inc. | 279 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211072 | 2021-04-27 |
| K081739 | 2008-12-03 |
| K072476 | 2007-12-14 |
| K031538 | 2003-06-27 |
| K030855 | 2003-04-17 |
| K022648 | 2002-09-05 |
| K020120 | 2002-08-02 |
| K014297 | 2002-07-09 |
| K962375 | 1996-09-04 |
| K924850 | 1994-12-29 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-02-20 | Class II | Process design | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events whi | 13 units (Japan) | |
| 2024-02-20 | Class II | Process design | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events whi | 1475 units | |
| 2024-02-20 | Class II | Process design | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events whi | 2501 units | |
| 2009-05-05 | Not classified | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 1490 | 2010-10-13 |
| 2009-05-05 | Not classified | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 238 | 2010-10-13 |
| 2009-05-05 | Not classified | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 266 | 2010-10-13 |
| 2009-05-05 | Not classified | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 4276 | 2010-10-13 |
| 2009-05-05 | Not classified | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 200 | 2010-10-13 |
| 2009-05-05 | Not classified | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 525 | 2010-10-13 |
| 2009-05-05 | Not classified | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 140 | 2010-10-13 |
| 2009-05-05 | Not classified | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 3124 | 2010-10-13 |
| 2008-12-30 | Not classified | Other | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 2460 of all products | 2009-10-30 |
| 2008-12-30 | Not classified | Other | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 2460 of all products | 2009-10-30 |
| 2008-12-30 | Not classified | Other | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 2460 of all products | 2009-10-30 |
| 2008-12-30 | Not classified | Other | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. | 2460 of all products | 2009-10-30 |
| 2005-06-02 | Not classified | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. | 2006-12-13 | |
| 2005-06-02 | Not classified | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. | 2006-12-13 |
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.