510(k) K231299
- Device
- Nutricair enteral ENFit adapter: ENFit male ? stepped/Christmas tree connector
- Applicant
- Cair Lgl
- 510(k) number
- K231299
- Product code
- PIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-22
- Date received
- 2023-05-04
- Regulation
- 876.5980
- Classification name
- Enteral Specific Transition Connectors
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Irving L Wiesen
- Address
- 1, Allée Des Chevreuls Lissieu FR 69380 69380
FDA Registration Numbers#
- 1417592
- 3023275185
- 3004472854
- 1423537
- 3012494290
- 3014662855
- 3011237770
- 8020785
- 1526012
- 9612030
- 9611594
- 3012441761
- 3013788631
- 3006673317
- 3015433750
- 3038294399
- 3003593728
- 3007441619
- 3036722184
Source Documents#
Other 510(k) Records For Product Code PIO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233190 | ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd | 2024-01-18 |
| K220165 | Enteral Transition Adaptor | GBUK Group, Ltd. | 2022-10-21 |
| K162254 | Cedic Enteral ENFit Transition Connectors | Cedic S.R.L. | 2017-05-04 |
| K151237 | Nutrisafe 2- ENFit Adaptor | Vygon | 2016-02-09 |
| K151628 | Medline ENFit Connectors | Medline Industries, Inc. | 2015-07-24 |
| K150034 | AMT Enteral Transition Adapters | Applied Medical Technology, Inc. | 2015-06-09 |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port | Cedic S.R.L. | 2015-04-02 |
| K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT | Cedic S.R.L. | 2014-10-17 |