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)
Top companies in KNT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2022 | Avanos Medical, Inc. Avanos Cortrak 2 Enteral Access System (EAS) Terminated |
KNT | K113351 K191340 |
| Dec 22, 2021 | Avanos Medical, Inc. MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL Terminated |
KNT | K924065 |
| Dec 22, 2021 | Avanos Medical, Inc. MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL Terminated |
KNT | K924065 |
| Feb 11, 2021 | Hollister 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 |
KNT | K932855 |
| Oct 16, 2020 | Avanos Medical, Inc. CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector Terminated |
KNT | K043044 |
| Jul 29, 2020 | Avanos Medical, Inc. AVANOS MIC-KEY SF Gastrostomy Feeding Tube Terminated |
KNT | K122653 |
| Oct 8, 2019 | Avanos 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 |
KNT | K882867 |
| Oct 8, 2019 | Avanos 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 |
KNT | K882867 |
| Oct 31, 2018 | COVIDIEN 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 |
KNT | K810156 |
| Oct 24, 2018 | Neomed 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 |
KNT | K100288 |
| Apr 12, 2018 | Teleflex Medical Europe Ltd Baker Jejunostomy Tubes:
Product Code Equivalent Code
(a) 655300160 655316
(b) 655500200 655520 Terminated |
KNT | K841035 |
| Oct 19, 2017 | Cook Inc. Wills-Oglesby Percutaneous Gastrostomy Set
Product Usage:
Intended for the percutaneous placement of a catheter for gastroenteric feeding Terminated |
KNT | None listed |
| Oct 19, 2017 | Cook Inc. Percutaneous Gastrojejunostomy Set
Product Usage:
Intended for the percutaneous placement of a catheter for gastroenteric feeding Terminated |
KNT | None listed |
| Oct 19, 2017 | Cook Inc. Mallinckrodt Institute Percutaneous Gastrostomy Set
Product Usage:
Intended for the percutaneous placement of a catheter for gastroenteric feeding Terminated |
KNT | None listed |
| Sep 21, 2017 | Covidien 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 |
KNT | K143083 K160654 |
| Apr 27, 2017 | AbbVie Inc. AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. Terminated |
KNT | K142793 |
| Apr 27, 2017 | AbbVie Inc. AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. Terminated |
KNT | K142793 |
| Apr 27, 2017 | AbbVie Inc. AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. Terminated |
KNT | K142793 |
| Feb 17, 2017 | Applied Medical Technology Inc AMT 12 inch Right Angle Feeding Set with Y-Port
Used with Nasogastric/Nasointestinal (NG/NI) tubes. Terminated |
KNT | K030784 K142971 |
| Feb 17, 2017 | Applied Medical Technology Inc AMT Bridle - Nasal Tube Retaining System
Used with Nasogastric/Nasointestinal (NG/NI) tubes. Terminated |
KNT | K030784 K142971 |
| Feb 3, 2017 | CORPAK 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 |
KNT | K882867 |
| Feb 3, 2017 | CORPAK 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 |
KNT | K882867 |
| Feb 3, 2017 | CORPAK 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 |
KNT | K882867 |
| Nov 22, 2016 | AbbVie Inc. AbbVie PEG Kit 20 FR Terminated |
KNT | K142793 |
| Mar 2, 2016 | Covidien 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 |
KNT | K820442 |
| Mar 2, 2016 | Covidien 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 |
KNT | K820442 |
| Jan 26, 2016 | Applied 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 |
KNT | K110804 K123716 |
| Nov 25, 2015 | Abeon 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 |
KNT | None listed |
| Jun 13, 2014 | Convatec 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 |
KNT | None listed |
| Apr 24, 2014 | Teleflex 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 |
KNT | K981203 |
| Aug 20, 2013 | Convatec 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 |
KNT | K032734 |
| Aug 20, 2013 | Convatec 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 |
KNT | K032734 |
| Sep 20, 2012 | Kimberly-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 |
KNT | None listed |
| Sep 20, 2012 | Kimberly-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 |
KNT | None listed |
| Feb 22, 2012 | Corpak 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 |
KNT | K821906 |
| Feb 2, 2012 | Kimberly-Clark Corporation KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F.
Gastro-Enteric Feeding Tube. Terminated |
KNT | K852707 |
| Nov 22, 2011 | Ethox International, Inc. TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage Terminated |
KNT | K812648 |
| Nov 26, 2010 | C.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 |
KNT | None listed |
| Mar 24, 2010 | Churchill 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 |
KNT | K060944 K991918 |
| Mar 24, 2010 | Churchill 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 |
KNT | K060944 K991918 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire", REF 006036, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., FASTRAC Guidewire Gastric Access Port Kit, REF 005739, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" REF 003030, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.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 |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.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 |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.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 |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.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 |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Kit, REF 007082, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
| Sep 15, 2009 | C.R. Bard Access Systems, Inc Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007078, 20F, Sterile. Terminated |
KNT | K033562 K061021 +3 |
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