Cleared Traditional

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

K242212 · Nemoto Kyorindo Co., Ltd. · General Hospital
Aug 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K242212 is an FDA 510(k) clearance for the Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit), a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Nemoto Kyorindo Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on August 27, 2024, 29 days after receiving the submission on July 29, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K242212 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2024
Decision Date August 27, 2024
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code DXT — Injector And Syringe, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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