VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
FDA 510(k) clearance K180236 · decided 2019-01-18
Clearance details
- K-number
- K180236
- Device name
- VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
- Applicant
- Vr Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-01-29
- Decision date
- 2019-01-18
- Days to decision
- 354 days
- Clearance type
- Traditional
- Product code
- FPD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Zhouzhuang, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Nutrifit (K243361) | Vygon USA | 2024-12-19 |
| INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (K131590) | Philips Medical Systems | 2013-10-23 |
| INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (K120815) | Philips Medical Systems | 2013-03-06 |
| NUTRISAFE 2 FEEDING TUBE (K121105) | Vygon Corp. | 2012-12-18 |
| NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (K100163) | Vygon Corp. | 2011-10-13 |
| VR MEDICAL ENTERAL ORAL SYRINGE (K110853) | Vr Medical | 2011-05-13 |
| MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (K100700) | Benlan, Inc. | 2010-12-13 |
| GUARDIAN CONNECTION (K101214) | Maulin Medical, LLC | 2010-07-23 |
| ORAL/ENTERAL SYRINGES (K100099) | Philips Children'S Medical Ventures | 2010-06-14 |
| AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (K100526) | Kentec Medical, Inc. | 2010-04-22 |
| THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 (K091340) | Boston Scientific Corp | 2009-06-09 |
| CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S (K083776) | Corpak Medsystems | 2009-03-05 |
Recalls involving this device
No recalls on record reference this clearance.