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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2025 | K242211 | PUMA-G Pediatric System Coaptech, Inc. | KGC |
| Mar 29, 2023 | K223916 | PUMA-G System Coaptech, Inc. | KGC |
| Mar 12, 2020 | K193612 | AMT Suture Delivery System Applied Medical Technology, Inc. | KGC |
| Sep 30, 2019 | K191844 | Fidmi Low Profile Enteral Feeding Device Fidmi Medical, Ltd., IL | KGC |
| Jun 26, 2019 | K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set Cook Incorporated | KGC |
| Apr 10, 2019 | K183057 | PUMA-G System Coaptech, LLC | KGC |
| Sep 14, 2017 | K170323 | Entuit Start Initial Placement Gastrostomy Set Cook Incorporated | KGC |
| May 25, 2012 | K120587 | AMT T-FASTENER ANCHOR KIT Applied Medical Technology, Inc. | KGC |
| Dec 8, 2009 | K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM Kimberly-Clark Corp. | KGC |
| Mar 19, 2008 | K073718 | MEDLINE GASTROSTOMY TUBE Medline Industries, Inc. | KGC |
| Feb 26, 2008 | K080253 | KIMBERLY-CLARK INTRODUCER KITS Kimberly-Clark Corp. | KGC |
| Apr 10, 1998 | K980145 | AMT DECOMPRESSION TUBES Applied Medical Technology, Inc. | KGC |
| Jul 24, 1991 | K910492 | BARD REPLACEMENT GASTROSTOMY TUBE C.R. Bard, Inc. | KGC |
| May 23, 1991 | K910584 | ONE STEP BUTTON(TM) Applied Medical Technologies | KGC |
| Jan 18, 1991 | K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE C.R. Bard, Inc. | KGC |
| Jan 16, 1991 | K904801 | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE Orion Life Systems, Inc. | KGC |
| Nov 20, 1990 | K903086 | TUBE GASTROSTOMY Knight Medical, Inc. | KGC |
| Nov 19, 1990 | K903036 | P.R.G. GUIDEWIRE PLACEMENT SYSTEM Applied Medical Technologies | KGC |
| Aug 8, 1990 | K901795 | GASTROSTOMY FEEDING CATHETER Southside Biotechnology | KGC |
| Aug 8, 1990 | K901791 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH. Southside Biotechnology | KGC |
| Jul 27, 1990 | K902121 | LAKE GASTROSTOMY TUBE Lake Medical Products, Inc. | KGC |
| Jul 2, 1990 | K900884 | P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY Applied Medical Technologies | KGC |
| Jun 11, 1990 | K901501 | CORPAK GASTROSTOMY TUBE Corpak Co. | KGC |
| Dec 21, 1989 | K894653 | NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR Superior Biosystems, Inc. | KGC |
| Mar 12, 1986 | K860441 | ENTROKIT WITH MAGLINTE CATHETER Lafayette Pharmacal, Inc. | KGC |
| Oct 24, 1978 | K781333 | CENTRAL CATHETER TRAY Argon Medical Corp. | KGC |
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