K130023 is an FDA 510(k) clearance for the K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Np Medical, Inc. (South Lyon, US). The FDA issued a Cleared decision on April 3, 2013, 90 days after receiving the submission on January 3, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K130023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2013 |
| Decision Date | April 03, 2013 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |