K060231 is an FDA 510(k) clearance for the CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on April 13, 2006, 73 days after receiving the submission on January 30, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K060231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2006 |
| Decision Date | April 13, 2006 |
| Days to Decision | 73 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG - Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |