SafeR Syringe and SafeR Sting
K-Number: K221981 · 2022-12-29
ApplicantRoncadelle Operations Srl
Decision Date2022-12-29
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SafeR Syringe and SafeR Sting is a medical device manufactured by Roncadelle Operations Srl. It received FDA 510(k) clearance on 2022-12-29 under approval number K221981. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SafeR Syringe and SafeR Sting?
SafeR Syringe and SafeR Sting is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Roncadelle Operations Srl. The 510(k) number is K221981.
When was SafeR Syringe and SafeR Sting approved by the FDA?
SafeR Syringe and SafeR Sting received FDA 510(k) clearance on 2022-12-29, under approval number K221981.
What company makes SafeR Syringe and SafeR Sting?
SafeR Syringe and SafeR Sting is manufactured by Roncadelle Operations Srl.
What is the FDA product code for SafeR Syringe and SafeR Sting?
The FDA product code for SafeR Syringe and SafeR Sting is MEG.
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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.