VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
FDA 510(k) K180236 · Vr Medical Technology Co., Ltd.
510(k) numberK180236
Submission
- Device name
- VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
- Applicant
- Vr Medical Technology Co., Ltd.
Zhouzhuang, CN - Received
- January 29, 2018
- Decision date
- January 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K243361 | NutrifitFPD · Traditional | Vygon USA | 12/19/2024SE |
| K131590 | Innersense Esophageal Temperature Probe / Feeding TubeFPD · Traditional | Philips Medical Systems | 10/23/2013SE |
| K120815 | Innersense Esophageal Temperature/Feeding TubeFPD · Traditional | Philips Medical Systems | 03/06/2013SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | Vygon Corp. | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | Vygon Corp. | 10/13/2011SE |
| K110853 | VR Medical Enteral Oral SyringeFPD · Traditional | Vr Medical | 05/13/2011SE |
| K100700 | Med-Rx Pediatric Feeding Tubes and AccessoriesFPD · Traditional | Benlan, Inc. | 12/13/2010SE |
| K101214 | Guardian ConnectionFPD · Traditional | Maulin Medical, LLC | 07/23/2010SE |
| K100099 | Oral/Enteral SyringesFPD · Traditional | Philips Children'S Medical Ventures | 06/14/2010SE |
| K100526 | Ameritus Entral (TM) Enteral Feeding TubeFPD · Traditional | Kentec Medical, Inc. | 04/22/2010SE |
More from Kentec Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K162188 | Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low…PNR · Traditional | 09/22/2016SE |
Questions and answers
When was VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) cleared by the FDA?
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (K180236) received a 510(k) decision of Substantially Equivalent on January 18, 2019, 354 days after the submission was received.
What is the product code of K180236?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.