K190427 is an FDA 510(k) clearance for the Immucise. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Terumo Corporation (Shibuya-Ku, JP). The FDA issued a Cleared decision on July 18, 2019, 146 days after receiving the submission on February 22, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K190427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2019 |
| Decision Date | July 18, 2019 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |