Ameritus Entral (TM) Enteral Feeding Tube
FDA 510(k) K100526 · Kentec Medical, Inc.
510(k) numberK100526
Submission
- Device name
- Ameritus Entral (TM) Enteral Feeding Tube
- Applicant
- Kentec Medical, Inc.
Irvine, CA, US - Received
- February 24, 2010
- Decision date
- April 22, 2010
- 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 |
|---|---|---|
| K120272 | Ameritus Medical Enteral Feeding Extension SetKNT · Traditional | 02/17/2012SE |
| K050443 | Accu-LeadDRX · Traditional | 09/02/2005SE |
| K970686 | Accutemp-ProbeFMT · Traditional | 08/25/1997SE |
| K960080 | Accutemp ProbeFMT · Traditional | 05/01/1996SE |
| K853475 | Gram-Ma Neonatal SCFRW · Traditional | 09/05/1985SE |
Questions and answers
When was Ameritus Entral (TM) Enteral Feeding Tube cleared by the FDA?
Ameritus Entral (TM) Enteral Feeding Tube (K100526) received a 510(k) decision of Substantially Equivalent on April 22, 2010, 57 days after the submission was received.
What is the product code of K100526?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.