K092527 is an FDA 510(k) clearance for the NEXUS INJECTION SITE, MODEL NIS-8. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Nexus Medical, LLC (Lenexa, US). The FDA issued a Cleared decision on February 4, 2010, 170 days after receiving the submission on August 18, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K092527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2009 |
| Decision Date | February 04, 2010 |
| Days to Decision | 170 days |
| Submission Type | Special |
| 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 |