Oral/Enteral Syringes

FDA 510(k) K100099 · Philips Children'S Medical Ventures

Substantially Equivalent

510(k) numberK100099

Submission

Device name
Oral/Enteral Syringes
Applicant
Philips Children'S Medical Ventures
Monroeville, PA, US
Received
January 13, 2010
Decision date
June 14, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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
K243361NutrifitFPD · Traditional Vygon USA12/19/2024SE
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
K100526Ameritus Entral (TM) Enteral Feeding TubeFPD · Traditional Kentec Medical, Inc.04/22/2010SE

Questions and answers

When was Oral/Enteral Syringes cleared by the FDA?

Oral/Enteral Syringes (K100099) received a 510(k) decision of Substantially Equivalent on June 14, 2010, 152 days after the submission was received.

What is the product code of K100099?

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