K860781 is an FDA 510(k) clearance for the ICU MEDICAL NEEDLE, LOPEZ NEEDLE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Icu Medical, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on May 6, 1986, 64 days after receiving the submission on March 3, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K860781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1986 |
| Decision Date | May 06, 1986 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |