Atlas FDA

KGC

26 FDA 510(k) clearances · Product code

90 daysmedian time to decision
225 days90th percentile
26clearances measured

FDA profile

Official device name
Tube, Gastro-Enterostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 73 · 2022: 51 · 2023: 36 · 2024: 87 · 2025: 107 · 2026: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PUMA-G Pediatric System (K242211)Coaptech, Inc.2025-04-29
PUMA-G System (K223916)Coaptech, Inc.2023-03-29
AMT Suture Delivery System (K193612)Applied Medical Technology, Inc.2020-03-12
Fidmi Low Profile Enteral Feeding Device (K191844)Fidmi Medical, Ltd.2019-09-30
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (K182832)Cook Incorporated2019-06-26
PUMA-G System (K183057)Coaptech, LLC2019-04-10
Entuit Start Initial Placement Gastrostomy Set (K170323)Cook Incorporated2017-09-14
AMT T-FASTENER ANCHOR KIT (K120587)Applied Medical Technology, Inc.2012-05-25
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM (K093312)Kimberly-Clark Corp.2009-12-08
MEDLINE GASTROSTOMY TUBE (K073718)Medline Industries, Inc.2008-03-19
KIMBERLY-CLARK INTRODUCER KITS (K080253)Kimberly-Clark Corp.2008-02-26
AMT DECOMPRESSION TUBES (K980145)Applied Medical Technology, Inc.1998-04-10
BARD REPLACEMENT GASTROSTOMY TUBE (K910492)C.R. Bard, Inc.1991-07-24
ONE STEP BUTTON(TM) (K910584)Applied Medical Technologies1991-05-23
BUTTON REPLACEMENT GASTROSTOMY DEVICE (K904779)C.R. Bard, Inc.1991-01-18
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE (K904801)Orion Life Systems, Inc.1991-01-16
TUBE GASTROSTOMY (K903086)Knight Medical, Inc.1990-11-20
P.R.G. GUIDEWIRE PLACEMENT SYSTEM (K903036)Applied Medical Technologies1990-11-19
GASTROSTOMY FEEDING CATHETER (K901795)Southside Biotechnology1990-08-08
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH. (K901791)Southside Biotechnology1990-08-08
LAKE GASTROSTOMY TUBE (K902121)Lake Medical Products, Inc.1990-07-27
P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY (K900884)Applied Medical Technologies1990-07-02
CORPAK GASTROSTOMY TUBE (K901501)Corpak Co.1990-06-11
NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR (K894653)Superior Biosystems, Inc.1989-12-21
ENTROKIT WITH MAGLINTE CATHETER (K860441)Lafayette Pharmacal, Inc.1986-03-12
CENTRAL CATHETER TRAY (K781333)Argon Medical Corp.1978-10-24

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Every clearance here is in the API, with alerts when new ones post.