Submission Details
| 510(k) Number | K170988 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 03, 2017 |
| Decision Date | December 12, 2017 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
DropSafe Safety Pen Needle
Dec 2017
Decision
253d
Days
Class 2
Risk
About This 510(k) Submission
K170988 is an FDA 510(k) clearance for the DropSafe Safety Pen Needle, 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 December 12, 2017, 253 days after receiving the submission on April 3, 2017. 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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