Cleared Traditional

K213429 - AccuSert Needle Inserter
(FDA 510(k) Clearance)

K213429 · Emed Technologies Corporation · General Hospital
Oct 2022
Decision
364d
Days
Class 2
Risk

K213429 is an FDA 510(k) clearance for the AccuSert Needle Inserter, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Emed Technologies Corporation (El Dorado Hills, US). The FDA issued a Cleared decision on October 20, 2022, 364 days after receiving the submission on October 21, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K213429 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2021
Decision Date October 20, 2022
Days to Decision 364 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920