Nutrifit

FDA 510(k) K243361 · Vygon USA

Substantially Equivalent

510(k) numberK243361

Submission

Device name
Nutrifit
Applicant
Vygon USA
Lansdale Montgomery, PA, US
Received
October 29, 2024
Decision date
December 19, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FPD – Tube, Feeding
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FPD

510(k)DeviceApplicantDecision
K180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)FPD · Traditional Vr Medical Technology Co., Ltd.01/18/2019SE
K131590Innersense Esophageal Temperature Probe / Feeding TubeFPD · Traditional Philips Medical Systems10/23/2013SE
K120815Innersense Esophageal Temperature/Feeding TubeFPD · Traditional Philips Medical Systems03/06/2013SE
K121105Nutrisafe 2 Feeding TubeFPD · Traditional Vygon Corp.12/18/2012SE
K100163Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional Vygon Corp.10/13/2011SE
K110853VR Medical Enteral Oral SyringeFPD · Traditional Vr Medical05/13/2011SE
K100700Med-Rx Pediatric Feeding Tubes and AccessoriesFPD · Traditional Benlan, Inc.12/13/2010SE
K101214Guardian ConnectionFPD · Traditional Maulin Medical, LLC07/23/2010SE
K100099Oral/Enteral SyringesFPD · Traditional Philips Children'S Medical Ventures06/14/2010SE
K100526Ameritus Entral (TM) Enteral Feeding TubeFPD · Traditional Kentec Medical, Inc.04/22/2010SE

More from Kentec Medical, Inc.

510(k)DeviceDecision
K212370Leaderflex Mini and Leaderflex NanoFOZ · Traditional 08/29/2022SE
K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…PND · Traditional 11/02/2018SE
K172899Vygon PICCsLJS · Traditional 02/26/2018SE

Questions and answers

When was Nutrifit cleared by the FDA?

Nutrifit (K243361) received a 510(k) decision of Substantially Equivalent on December 19, 2024, 51 days after the submission was received.

What is the product code of K243361?

The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.