VR Medical Enteral Oral Syringe
FDA 510(k) K110853 · Vr Medical
510(k) numberK110853
Submission
- Device name
- VR Medical Enteral Oral Syringe
- Applicant
- Vr Medical
Zhouzhuang, CN - Received
- March 28, 2011
- Decision date
- May 13, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)FPD · Traditional | Vr Medical Technology Co., Ltd. | 01/18/2019SE |
| 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 |
| 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 |
|---|---|---|
| K132709 | VR Medical Heat and Moisture Exchanger and FilterCAH · Traditional | 07/30/2014SE |
Questions and answers
When was VR Medical Enteral Oral Syringe cleared by the FDA?
VR Medical Enteral Oral Syringe (K110853) received a 510(k) decision of Substantially Equivalent on May 13, 2011, 46 days after the submission was received.
What is the product code of K110853?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.