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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Emed Technologies Corporation. It received FDA 510(k) clearance on 2022-10-20 under 510(k) 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. The listed applicant is Emed Technologies Corporation. The 510(k) number is K213429.

When did AccuSert Needle Inserter receive FDA 510(k) clearance?

AccuSert Needle Inserter received FDA 510(k) clearance on 2022-10-20, under 510(k) number K213429.

Who is the listed applicant for AccuSert Needle Inserter?

The FDA 510(k) record lists Emed Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuSert Needle Inserter?

The FDA product code for AccuSert Needle Inserter is KZH.

Other records listing Emed Technologies Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251105Tetra (TM-20); Tetra (TM-50)K240148SCIg60 Infusion SystemK230883VersaPump Infusion SystemK222087SCIg60 Infusion SystemK173783SCIg60 Infusion SystemK161906SCIg60 Infuser

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Related Devices (Code: KZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243232GripMateSynthon Hispania S.L.K163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic Minimed

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.

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