Product code KGC
- Device name
- Tube, Gastro-Enterostomy
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242211 | PUMA-G Pediatric System | Coaptech, Inc. | 2025-04-29 |
| K223916 | PUMA-G System | Coaptech, Inc. | 2023-03-29 |
| K193612 | AMT Suture Delivery System | Applied Medical Technology, Inc. | 2020-03-12 |
| K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | 2019-09-30 |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | 2019-06-26 |
| K183057 | PUMA-G System | Coaptech, LLC | 2019-04-10 |
| K170323 | Entuit Start Initial Placement Gastrostomy Set | Cook Incorporated | 2017-09-14 |
| K120587 | AMT T-FASTENER ANCHOR KIT | Applied Medical Technology, Inc. | 2012-05-25 |
| K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM | Kimberly-Clark Corp. | 2009-12-08 |
| K073718 | MEDLINE GASTROSTOMY TUBE | Medline Industries, Inc. | 2008-03-19 |
| K080253 | KIMBERLY-CLARK INTRODUCER KITS | Kimberly-Clark Corp. | 2008-02-26 |
| K980145 | AMT DECOMPRESSION TUBES | Applied Medical Technology, Inc. | 1998-04-10 |
| K910492 | BARD REPLACEMENT GASTROSTOMY TUBE | C.R. Bard, Inc. | 1991-07-24 |
| K910584 | ONE STEP BUTTON(TM) | Applied Medical Technologies | 1991-05-23 |
| K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE | C.R. Bard, Inc. | 1991-01-18 |
| K904801 | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE | Orion Life Systems, Inc. | 1991-01-16 |
| K903086 | TUBE GASTROSTOMY | Knight Medical, Inc. | 1990-11-20 |
| K903036 | P.R.G. GUIDEWIRE PLACEMENT SYSTEM | Applied Medical Technologies | 1990-11-19 |
| K901791 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH. | Southside Biotechnology | 1990-08-08 |
| K901795 | GASTROSTOMY FEEDING CATHETER | Southside Biotechnology | 1990-08-08 |
| K902121 | LAKE GASTROSTOMY TUBE | Lake Medical Products, Inc. | 1990-07-27 |
| K900884 | P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY | Applied Medical Technologies | 1990-07-02 |
| K901501 | CORPAK GASTROSTOMY TUBE | Corpak Co. | 1990-06-11 |
| K894653 | NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR | Superior Biosystems, Inc. | 1989-12-21 |
| K860441 | ENTROKIT WITH MAGLINTE CATHETER | Lafayette Pharmacal, Inc. | 1986-03-12 |
| K781333 | CENTRAL CATHETER TRAY | Argon Medical Corp. | 1978-10-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850026037170 | PUMA-G Pediatric System™ | Coaptech, Inc. | 2025-12-23 |
| 10860312001532 | PUMA-G System™ | Coaptech, Inc. | 2024-05-16 |
| 00350770987064 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770987057 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770987040 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770987033 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770987026 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770984384 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770984377 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770915210 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770915227 | AVANOS | Avanos Medical, Inc. | 2020-05-23 |
| 00350770984605 | AVANOS | Avanos Medical, Inc. | 2019-09-08 |
| 08714729149217 | EndoVive™ One Step Button™ | BOSTON SCIENTIFIC CORPORATION | 2018-09-07 |
| 08714729151081 | EndoVive™ One Step Button™ | BOSTON SCIENTIFIC CORPORATION | 2018-09-07 |
| 08714729150084 | EndoVive™ One Step Button™ | BOSTON SCIENTIFIC CORPORATION | 2018-09-07 |
| 08714729149941 | EndoVive™ One Step Button™ | BOSTON SCIENTIFIC CORPORATION | 2018-09-07 |
| 08714729149934 | EndoVive™ One Step Button™ | BOSTON SCIENTIFIC CORPORATION | 2018-09-07 |
| 08714729149231 | EndoVive™ One Step Button™ | BOSTON SCIENTIFIC CORPORATION | 2018-09-07 |
| 08714729149224 | EndoVive™ One Step Button™ | BOSTON SCIENTIFIC CORPORATION | 2018-09-07 |
| 08714729149200 | EndoVive™ One Step Button™ | BOSTON SCIENTIFIC CORPORATION | 2018-09-07 |
| 10680651984606 | Halyard | Avanos Medical, Inc. | 2016-07-06 |
| 00801741080968 | Bard Button Device Decompression Tube | Bard Access Systems, Inc. | 2015-09-24 |
| 00801741080951 | Bard Button Device Decompression Tube | Bard Access Systems, Inc. | 2015-09-24 |
| 00801741080944 | Bard Button Device Decompression Tube | Bard Access Systems, Inc. | 2015-09-24 |
| 00801741080876 | Bard Button Bolus Feeding Tube with Straight Adaptor | Bard Access Systems, Inc. | 2015-09-24 |
| 00801741080869 | Bard Button Device Continuous Feeding Tube with 90 degree Adapter | Bard Access Systems, Inc. | 2015-09-24 |
| 00801741080852 | Bard Button Device Bolus Feeding Tube with Straight Adaptor | Bard Access Systems, Inc. | 2015-09-24 |
| 00801741080845 | Bard Button Device Continuous Feeding Tube with 90° Adaptor | Bard Access Systems, Inc. | 2015-09-24 |
| 00801741080838 | Bard Button Device Bolus Device Bolus Feeding Tube with Straight Adaptor | Bard Access Systems, Inc. | 2015-09-24 |
| 00801741080821 | Bard Button Device Continuous Feeding Tube 90 degree Adaptor | Bard Access Systems, Inc. | 2015-09-24 |