DropSafe Safety Pen Needles
K-Number: K211716 · 2022-01-07
ApplicantHtl Strefa SA
Decision Date2022-01-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
DropSafe Safety Pen Needles is a medical device manufactured by Htl Strefa SA. It received FDA 510(k) clearance on 2022-01-07 under approval number K211716. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DropSafe Safety Pen Needles?
DropSafe Safety Pen Needles is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Htl Strefa SA. The 510(k) number is K211716.
When was DropSafe Safety Pen Needles approved by the FDA?
DropSafe Safety Pen Needles received FDA 510(k) clearance on 2022-01-07, under approval number K211716.
What company makes DropSafe Safety Pen Needles?
DropSafe Safety Pen Needles is manufactured by Htl Strefa SA.
What is the FDA product code for DropSafe Safety Pen Needles?
The FDA product code for DropSafe Safety Pen Needles is FMI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.