Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit
FDA 510(k) K071191 · Novartis Nutrition Corp.
510(k) numberK071191
Submission
- Device name
- Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit
- Applicant
- Novartis Nutrition Corp.
St. Louis Park, MN, US - Received
- April 30, 2007
- Decision date
- July 23, 2007
- 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 |
| 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 |
|---|---|---|
| K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and 1000 ML Waer…KNT · Special | 03/05/2008SE |
| K001916 | Compat Replacement Gastrostomy Tube Kit, Model 0974XXKNT · Traditional | 02/16/2001SE |
| K991668 | Compat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12)KNT · Traditional | 07/26/1999SE |
| K981323 | Compat Mini-G Replacement Gastrostomy TubeKNT · Traditional | 10/09/1998SE |
Questions and answers
When was Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit cleared by the FDA?
Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit (K071191) received a 510(k) decision of Substantially Equivalent on July 23, 2007, 84 days after the submission was received.
What is the product code of K071191?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.