AccuSert Needle Inserter
K-Number: K213429 · 2022-10-20
ApplicantEmed Technologies Corporation
Decision Date2022-10-20
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
AccuSert Needle Inserter is a medical device manufactured by Emed Technologies Corporation. It received FDA 510(k) clearance on 2022-10-20 under approval number K213429. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AccuSert Needle Inserter?
AccuSert Needle Inserter is a medical device that received FDA 510(k) clearance on 2022-10-20. It is manufactured by Emed Technologies Corporation. The 510(k) number is K213429.
When was AccuSert Needle Inserter approved by the FDA?
AccuSert Needle Inserter received FDA 510(k) clearance on 2022-10-20, under approval number K213429.
What company makes AccuSert Needle Inserter?
AccuSert Needle Inserter is manufactured by Emed Technologies Corporation.
What is the FDA product code for AccuSert Needle Inserter?
The FDA product code for AccuSert Needle Inserter is KZH.
Other Devices by Emed Technologies Corporation
Related Devices (Code: KZH)
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.