Cleared Special

A-TAP (previously called Arthrotap)

K231900 · Elcam Medical Acal · General Hospital
Jul 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K231900 is an FDA 510(k) clearance for the A-TAP (previously called Arthrotap), a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Elcam Medical Acal (Baram, IL). The FDA issued a Cleared decision on July 25, 2023, 27 days after receiving the submission on June 28, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K231900 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2023
Decision Date July 25, 2023
Days to Decision 27 days
Submission Type Special
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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