Panels › Gastroenterology, Urology › Product code PIO · Class 2
Enteral Specific Transition Connectors
Regulation 876.5980
0510(k)s in 12 months (9 all time)
2recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in PIO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cedic S.R.L. | 3 | 0 |
| Medline Industries, Inc. | 1 | 2 |
| Applied Medical Technology, Inc. | 1 | 1 |
| Cair Lgl | 1 | 0 |
| GBUK Group, Ltd. | 1 | 0 |
| Jiangsu Caina Medical Co.,Ltd | 1 | 0 |
| Vygon | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2024 | K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector Cair Lgl, FR | PIO |
| Jan 18, 2024 | K233190 | ENFit Adaptor Jiangsu Caina Medical Co.,Ltd, CN | PIO |
| Oct 21, 2022 | K220165 | Enteral Transition Adaptor GBUK Group, Ltd., GB | PIO |
| May 4, 2017 | K162254 | Cedic Enteral ENFit Transition Connectors Cedic S.R.L., IT | PIO |
| Feb 9, 2016 | K151237 | Nutrisafe 2- ENFit Adaptor Vygon | PIO |
| Jul 24, 2015 | K151628 | Medline ENFit Connectors Medline Industries, Inc. | PIO |
| Jun 9, 2015 | K150034 | AMT Enteral Transition Adapters Applied Medical Technology, Inc. | PIO |
| Apr 2, 2015 | K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port Cedic S.R.L., IT | PIO |
| Oct 17, 2014 | K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT Cedic S.R.L., IT | PIO |
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