Cleared Traditional

aboNT SYRINGE

K212677 · Nipro Medical Corporation · General Hospital
Apr 2022
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K212677 is an FDA 510(k) clearance for the aboNT SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on April 15, 2022, 234 days after receiving the submission on August 24, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K212677 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2021
Decision Date April 15, 2022
Days to Decision 234 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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