NEOMED Enteral FEEDING TUBE
FDA 510(k) K072881 · Neomed, Inc.
510(k) numberK072881
Submission
- Device name
- NEOMED Enteral FEEDING TUBE
- Applicant
- Neomed, Inc.
Swanee, GA, US - Received
- October 9, 2007
- Decision date
- January 9, 2008
- 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 |
| 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 |
| 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 |
More from Philips Children'S Medical Ventures
| 510(k) | Device | Decision |
|---|---|---|
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…PNR · Traditional | 04/30/2019SE |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…PNR · Traditional | 06/17/2016SE |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsPNR · Traditional | 12/17/2015SE |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit ConnectorPNR · Traditional | 04/09/2015SE |
| K122373 | Neomed Oral/Enteral SyringeFMF · Special | 09/20/2012SE |
| K120182 | Neomed Gastrointestinal Tube and AccessoriesKNT · Traditional | 04/19/2012SE |
| K100288 | Neomed Enteral Only Extension SetKNT · Traditional | 08/03/2010SE |
| K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…FMF · Traditional | 03/10/2010SE |
| K082238 | Neomed Polyurethane Feeding TubeFPD · Special | 10/01/2008SE |
| K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0FOS · Special | 07/21/2008SE |
Questions and answers
When was NEOMED Enteral FEEDING TUBE cleared by the FDA?
NEOMED Enteral FEEDING TUBE (K072881) received a 510(k) decision of Substantially Equivalent on January 9, 2008, 92 days after the submission was received.
What is the product code of K072881?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.