ClearanceBrief
Panels › Gastroenterology, Urology › Product code KNT · Class 2

Tubes, Gastrointestinal (And Accessories)

Regulation 876.5980

3510(k)s in 12 months (652 all time)
26recalls in 12 months (268 all time)
191recalls that name a 510(k)
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Top companies in KNT

DateFirm and productCodeLinked 510(k)
May 13, 2022Avanos Medical, Inc.
Avanos Cortrak 2 Enteral Access System (EAS)
Terminated
KNTK113351
K191340
Dec 22, 2021Avanos Medical, Inc.
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Terminated
KNTK924065
Dec 22, 2021Avanos Medical, Inc.
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Terminated
KNTK924065
Feb 11, 2021Hollister Incorporated
Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-4
Terminated
KNTK932855
Oct 16, 2020Avanos Medical, Inc.
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Terminated
KNTK043044
Jul 29, 2020Avanos Medical, Inc.
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Terminated
KNTK122653
Oct 8, 2019Avanos Medical, Inc.
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
Terminated
KNTK882867
Oct 8, 2019Avanos Medical, Inc.
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
Terminated
KNTK882867
Oct 31, 2018COVIDIEN LLC
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents followi
Terminated
KNTK810156
Oct 24, 2018Neomed Inc
NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube
Terminated
KNTK100288
Apr 12, 2018Teleflex Medical Europe Ltd
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Terminated
KNTK841035
Oct 19, 2017Cook Inc.
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Terminated
KNTNone listed
Oct 19, 2017Cook Inc.
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Terminated
KNTNone listed
Oct 19, 2017Cook Inc.
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Terminated
KNTNone listed
Sep 21, 2017Covidien LLC
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decom
Terminated
KNTK143083
K160654
Apr 27, 2017AbbVie Inc.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Terminated
KNTK142793
Apr 27, 2017AbbVie Inc.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Terminated
KNTK142793
Apr 27, 2017AbbVie Inc.
AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Terminated
KNTK142793
Feb 17, 2017Applied Medical Technology Inc
AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Terminated
KNTK030784
K142971
Feb 17, 2017Applied Medical Technology Inc
AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Terminated
KNTK030784
K142971
Feb 3, 2017CORPAK MedSystems, Inc.
CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between th
Terminated
KNTK882867
Feb 3, 2017CORPAK MedSystems, Inc.
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adap
Terminated
KNTK882867
Feb 3, 2017CORPAK MedSystems, Inc.
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PE
Terminated
KNTK882867
Nov 22, 2016AbbVie Inc.
AbbVie PEG Kit 20 FR
Terminated
KNTK142793
Mar 2, 2016Covidien LLC
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
Terminated
KNTK820442
Mar 2, 2016Covidien LLC
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding.
Terminated
KNTK820442
Jan 26, 2016Applied Medical Technology Inc
AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.
Terminated
KNTK110804
K123716
Nov 25, 2015Abeon Medical Corporation
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
Terminated
KNTNone listed
Jun 13, 2014Convatec Inc.
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access
Terminated
KNTNone listed
Apr 24, 2014Teleflex Medical
Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instil
Terminated
KNTK981203
Aug 20, 2013Convatec Inc.
ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
Terminated
KNTK032734
Aug 20, 2013Convatec Inc.
ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administ
Terminated
KNTK032734
Sep 20, 2012Kimberly-Clark Corporation
Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement techniqu
Terminated
KNTNone listed
Sep 20, 2012Kimberly-Clark Corporation
Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement t
Terminated
KNTNone listed
Feb 22, 2012Corpak Med Systems
CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPA
Terminated
KNTK821906
Feb 2, 2012Kimberly-Clark Corporation
KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.
Terminated
KNTK852707
Nov 22, 2011Ethox International, Inc.
TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage
Terminated
KNTK812648
Nov 26, 2010C.R. Bard, Inc., Urological Division
Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non sterile, 12 Each, C.R. Bard, Inc., Covington, GA 30014
Terminated
KNTNone listed
Mar 24, 2010Churchill Medical Systems, Inc.
Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only Product Code: 1015.122M Vygon/Churchill Medical System
Terminated
KNTK060944
K991918
Mar 24, 2010Churchill Medical Systems, Inc.
Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 Product Code: 1015.062M Vygon/Churchill Medical System
Terminated
KNTK060944
K991918
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire", REF 006036, 20F, Sterile.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., FASTRAC Guidewire Gastric Access Port Kit, REF 005739, 20F, Sterile.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" REF 003030, 20F, Sterile.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, Sterile, Rx only, REF 000793, 20F.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, Sterile, Rx only, REF 000792, 20F.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, REF 000628, 20F.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, REF 000627, 20F.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Kit, REF 007082, 20F, Sterile.
Terminated
KNTK033562
K061021 +3
Sep 15, 2009C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007078, 20F, Sterile.
Terminated
KNTK033562
K061021 +3

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