K082836 is an FDA 510(k) clearance for the ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 25, 2009, 152 days after receiving the submission on September 26, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K082836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2008 |
| Decision Date | February 25, 2009 |
| Days to Decision | 152 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 |