Tube, Gastro-Enterostomy
FDA product code KGC · Class II (moderate risk) · 21 CFR 876.5980 · Gastroenterology, Urology
26510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Applied Medical Technologies 3
- Applied Medical Technology, Inc. 3
- Coaptech, Inc. 3
- Southside Biotechnology 2
- C.R. Bard, Inc. 2
- Kimberly-Clark Corp. 2
- Cook, Inc. 2
- Argon Medical Corp. 1
- Lafayette Pharmacal, Inc. 1
- Superior Biosystems, Inc. 1
- Corpak Co. 1
- Lake Medical Products, Inc. 1
- Knight Medical, Inc. 1
- Orion Life Systems, Inc. 1
- Medline Industries, LP 1
- Fidmi Medical, Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242211 | PUMA-G Pediatric SystemKGC · Traditional | Coaptech, Inc. | 04/29/2025SE |
| K223916 | PUMA-G SystemKGC · Traditional | Coaptech, Inc. | 03/29/2023SE |
| K193612 | AMT Suture Delivery SystemKGC · Traditional | Applied Medical Technology, Inc. | 03/12/2020SE |
| K191844 | Fidmi Low Profile Enteral Feeding DeviceKGC · Traditional | Fidmi Medical, Ltd. | 09/30/2019SE |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetKGC · Traditional | Cook Incorporated | 06/26/2019SESK |
| K183057 | PUMA-G SystemKGC · Traditional | Coaptech, LLC | 04/10/2019SE |
| K170323 | Entuit Start Initial Placement Gastrostomy SetKGC · Traditional | Cook Incorporated | 09/14/2017SE |
| K120587 | Amt T-Fastener Anchor KitKGC · Traditional | Applied Medical Technology, Inc. | 05/25/2012SESK |
| K093312 | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access…KGC · Special | Kimberly-Clark Corp. | 12/08/2009SE |
| K073718 | Medline Gastrostomy TubeKGC · Abbreviated | Medline Industries, Inc. | 03/19/2008SE |
| K080253 | Kimberly-Clark Introducer KitsKGC · Special | Kimberly-Clark Corp. | 02/26/2008SESK |
| K980145 | Amt Decompression TubesKGC · Traditional | Applied Medical Technology, Inc. | 04/10/1998SE |
| K910492 | Bard Replacement Gastrostomy TubeKGC · Traditional | C.R. Bard, Inc. | 07/24/1991SE |
| K910584 | One Step Button(Tm)KGC · Traditional | Applied Medical Technologies | 05/23/1991SE |
| K904779 | Button Replacement Gastrostomy DeviceKGC · Traditional | C.R. Bard, Inc. | 01/18/1991SE |
| K904801 | Orion Life Systems Replacement Gastrostomy TubeKGC · Traditional | Orion Life Systems, Inc. | 01/16/1991SE |
| K903086 | Tube GastrostomyKGC · Traditional | Knight Medical, Inc. | 11/20/1990SE |
| K903036 | P.R.G. Guidewire Placement SystemKGC · Traditional | Applied Medical Technologies | 11/19/1990SESD |
| K901795 | Gastrostomy Feeding CatheterKGC · Traditional | Southside Biotechnology | 08/08/1990SESK |
| K901791 | Percutaneous Endoscopic Gastrostomy Feeding Cath.KGC · Traditional | Southside Biotechnology | 08/08/1990SESK |
| K902121 | Lake Gastrostomy TubeKGC · Traditional | Lake Medical Products, Inc. | 07/27/1990SE |
| K900884 | P.R.G. Percutaneous Replacement GastrostomyKGC · Traditional | Applied Medical Technologies | 07/02/1990SESD |
| K901501 | Corpak Gastrostomy TubeKGC · Traditional | Corpak Co. | 06/11/1990SE |
| K894653 | No. 87500-NUPORT Peg Gastrostomy Tube Kit 22 FRKGC · Traditional | Superior Biosystems, Inc. | 12/21/1989SE |
| K860441 | Entrokit with Maglinte CatheterKGC · Traditional | Lafayette Pharmacal, Inc. | 03/12/1986SESD |
| K781333 | Central Catheter TrayKGC · Traditional | Argon Medical Corp. | 10/24/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0402-2016 Class II | One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button… | Boston Scientific Corp | 09/11/2015Terminated |
| Z-1745-2010 | ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498447 DISPOSABLE SINGLE USE, Rx.…There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the… | Argon Medical Devices, Inc | 03/29/2010Terminated |
| Z-1744-2010 | ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx.…There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the… | Argon Medical Devices, Inc | 03/29/2010Terminated |
| Z-1743-2010 | ARTERIAL LINE KIT REF/REORDER NO. 498412B DISPOSABLE SINGLE USE, Rx. Argon Medical…There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the… | Argon Medical Devices, Inc | 03/29/2010Terminated |
| Z-1742-2010 | ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical…There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the… | Argon Medical Devices, Inc | 03/29/2010Terminated |
| Z-1741-2010 | ARTERIAL LINE KIT REF/REORDER NO. 498410B DISPOSABLE, SINGLE USE, Rx. Argon Medical…There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the… | Argon Medical Devices, Inc | 03/29/2010Terminated |
| Z-1739-2010 | CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable…There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the… | Argon Medical Devices, Inc | 03/29/2010Terminated |
| Z-2021-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | C R Bard Inc | 01/20/2009Terminated |
| Z-2020-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | C R Bard Inc | 01/20/2009Terminated |
| Z-2019-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | C R Bard Inc | 01/20/2009Terminated |
| Z-2018-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | C R Bard Inc | 01/20/2009Terminated |
| Z-2017-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | C R Bard Inc | 01/20/2009Terminated |