Nutrisafe 2- ENFit Adaptor
FDA 510(k) K151237 · Vygon
510(k) numberK151237
Submission
- Device name
- Nutrisafe 2- ENFit Adaptor
- Applicant
- Vygon
Lansdale Montgomery, PA, US - Received
- May 11, 2015
- Decision date
- February 9, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PIO – Enteral Specific Transition Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
Other 510(k)s with product code PIO
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|---|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connectorPIO · Traditional | Cair Lgl | 01/22/2024SE |
| K233190 | ENFit AdaptorPIO · Traditional | Jiangsu Caina Medical Co.,Ltd | 01/18/2024SE |
| K220165 | Enteral Transition AdaptorPIO · Traditional | GBUK Group, Ltd. | 10/21/2022SE |
| K162254 | Cedic Enteral ENFit Transition ConnectorsPIO · Traditional | Cedic S.R.L. | 05/04/2017SE |
| K151628 | Medline ENFit ConnectorsPIO · Traditional | Medline Industries, Inc. | 07/24/2015SE |
| K150034 | AMT Enteral Transition AdaptersPIO · Traditional | Applied Medical Technology, Inc. | 06/09/2015SE |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortPIO · Traditional | Cedic S.R.L. | 04/02/2015SE |
| K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…PIO · Traditional | Cedic S.R.L. | 10/17/2014SE |
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Questions and answers
When was Nutrisafe 2- ENFit Adaptor cleared by the FDA?
Nutrisafe 2- ENFit Adaptor (K151237) received a 510(k) decision of Substantially Equivalent on February 9, 2016, 274 days after the submission was received.
What is the product code of K151237?
The FDA product code is PIO – Enteral Specific Transition Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.