Submission Details
| 510(k) Number | K192222 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 2019 |
| Decision Date | May 12, 2020 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
EZ-Inject Single use Needle
May 2020
Decision
270d
Days
Class 2
Risk
About This 510(k) Submission
K192222 is an FDA 510(k) clearance for the EZ-Inject Single use Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Poonglim Pharmatech, Inc. (Gunsan, KR). The FDA issued a Cleared decision on May 12, 2020, 270 days after receiving the submission on August 16, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
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