510(k) K243361

Device
Nutrifit
Applicant
Vygon USA
510(k) number
K243361
Product code
FPD
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-19
Date received
2024-10-29
Regulation
876.5980
Classification name
Tube, Feeding
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Chris Steinke
Address
2750 Morris Rd. Suite A200 Lansdale Montgomery PA US 19446 19446

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FPD

510(k)DeviceApplicantDecision date
K180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd.2019-01-18
K131590INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBEPhilips Medical Systems2013-10-23
K120815INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBEPhilips Medical Systems2013-03-06
K121105NUTRISAFE 2 FEEDING TUBEVygon Corp.2012-12-18
K100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXVygon Corp.2011-10-13
K110853VR MEDICAL ENTERAL ORAL SYRINGEVr Medical2011-05-13
K100700MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESBenlan, Inc.2010-12-13
K101214GUARDIAN CONNECTIONMaulin Medical, LLC2010-07-23
K100099ORAL/ENTERAL SYRINGESPhilips Children'S Medical Ventures2010-06-14
K100526AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEKentec Medical, Inc.2010-04-22
K091340THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350Boston Scientific Corp2009-06-09
K083776CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-SCorpak Medsystems2009-03-05
K083791CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-SCorpak Medsystems2009-03-04
K083786CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LBCorpak Medsystems2009-02-20
K083210CORFLO ANTI IV ENTERAL FEEDING TUBECorpak Medsystems2008-12-29