Mcgaw Nutra-Feed Efs Enteral Feeding Bag
FDA 510(k) K862090 · Kendall Mcgaw Laboratories, Inc.
510(k) numberK862090
Submission
- Device name
- Mcgaw Nutra-Feed Efs Enteral Feeding Bag
- Applicant
- Kendall Mcgaw Laboratories, Inc.
Santa Ana, CA, US - Received
- June 2, 1986
- Decision date
- October 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
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|---|---|---|
| K905611 | Microrate Plus Intelligent PumpFRN · Traditional | 03/01/1991SE |
| K905610 | Microrate Intelligent PumpFRN · Traditional | 03/01/1991SE |
| K904855 | Add-A-VialLHI · Traditional | 11/19/1990SE |
| K904518 | Volumetric Infusion PumpFRN · Traditional | 10/17/1990SE |
| K903809 | Protected Needle with or Without IV SetFPA · Traditional | 10/03/1990SE |
| K901065 | Infusion PumpFRN · Traditional | 08/21/1990SE |
| K900865 | Add-A-Vial II Binary ConnectorLHI · Traditional | 07/11/1990SE |
| K896292 | 1.2 Micron Filter with IV SetFPB · Traditional | 12/08/1989SE |
| K895109 | Secondary IV Set with Protected NeedleFPA · Traditional | 09/27/1989SE |
| K882159 | 522 Intelligent PumpFRN · Traditional | 08/24/1988SE |
Questions and answers
When was Mcgaw Nutra-Feed Efs Enteral Feeding Bag cleared by the FDA?
Mcgaw Nutra-Feed Efs Enteral Feeding Bag (K862090) received a 510(k) decision of Substantially Equivalent on October 3, 1986, 123 days after the submission was received.
What is the product code of K862090?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.