Submission Details
| 510(k) Number | K202340 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 2020 |
| Decision Date | October 15, 2020 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Droplet Pen Needle 30G & 33G
Oct 2020
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K202340 is an FDA 510(k) clearance for the Droplet Pen Needle 30G & 33G, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Htl-Strefa S.A (Ozorkow, PL). The FDA issued a Cleared decision on October 15, 2020, 59 days after receiving the submission on August 17, 2020. 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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