Panels › Gastroenterology, Urology › Product code KGC · Class 2
Tube, Gastro-Enterostomy
Regulation 876.5980
0510(k)s in 12 months (26 all time)
0recalls in 12 months (25 all time)
25recalls that name a 510(k)
Top companies in KGC
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 0 | 10 |
| C.R. Bard, Inc. | 2 | 5 |
| Argon Medical Devices, Inc | 0 | 6 |
| Bard Access Systems, Inc | 0 | 4 |
| Applied Medical Technologies | 3 | 0 |
| Applied Medical Technology, Inc. | 3 | 0 |
| Coaptech, Inc. | 3 | 0 |
| Cook Incorporated | 2 | 0 |
| Kimberly-Clark Corp. | 2 | 0 |
| Southside Biotechnology | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2015 | Boston Scientific Corp One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. Terminated |
KGC | K910584 |
| Jun 2, 2010 | Argon Medical Devices, Inc ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498447 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. Terminated |
KGC | K780871 |
| Jun 2, 2010 | Argon Medical Devices, Inc ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. Terminated |
KGC | K780871 |
| Jun 2, 2010 | Argon Medical Devices, Inc ARTERIAL LINE KIT REF/REORDER NO. 498412B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. Terminated |
KGC | K780871 |
| Jun 2, 2010 | Argon Medical Devices, Inc ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. Terminated |
KGC | K780871 |
| Jun 2, 2010 | Argon Medical Devices, Inc ARTERIAL LINE KIT REF/REORDER NO. 498410B DISPOSABLE, SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. Terminated |
KGC | K780871 |
| Jun 2, 2010 | Argon Medical Devices, Inc CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. Terminated |
KGC | K781333 |
| Sep 17, 2009 | C R Bard Inc Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA.
The device is designed for use wit Terminated |
KGC | K904779 |
| Sep 17, 2009 | C R Bard Inc Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF 000283, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA.
The device is designed for use wit Terminated |
KGC | K904779 |
| Sep 17, 2009 | C R Bard Inc Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA.
The device is designed for use wit Terminated |
KGC | K904779 |
| Sep 17, 2009 | C R Bard Inc Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON STERILE, REF 000292, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA.
The device is designed for use wit Terminated |
KGC | K904779 |
| Sep 17, 2009 | C R Bard Inc Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA.
The device is designed for use with the BA Terminated |
KGC | K904779 |
| May 3, 2006 | Bard Access Systems, Inc 24F Tri-Funnel Replacement Gastrostomy Tube Terminated |
KGC | K910492 |
| May 3, 2006 | Bard Access Systems, Inc 22F Tri-Funnel Replacement Gastrostomy Tube Terminated |
KGC | K910492 |
| May 3, 2006 | Bard Access Systems, Inc 20F Tri-Funnel Replacement Gastrostomy Tube Terminated |
KGC | K910492 |
| May 3, 2006 | Bard Access Systems, Inc 18F Tri-Funnel Replacement Gastrostomy Tube Terminated |
KGC | K910492 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/1.7 push; catalog number 6860. Terminated |
KGC | K910584 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/3.4 push; catalog number 6852. Terminated |
KGC | K910584 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/2.4 pull; catalog number 6851. Terminated |
KGC | K910584 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848. Terminated |
KGC | K910584 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, push; catalog number 6825. Terminated |
KGC | K031538 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824. Terminated |
KGC | K031538 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, push; catalog number 6821. Terminated |
KGC | K031538 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, pull; catalog number 6820. Terminated |
KGC | K031538 |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes) Kit, 18/2.4, pull; Catalog number 6314. Terminated |
KGC | K910584 |
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