Cleared Traditional

RNS ARTHROGRAM TRAY

K962040 · Contour Fabricators of Florida, Inc. · General Hospital
Jun 1996
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K962040 is an FDA 510(k) clearance for the RNS ARTHROGRAM TRAY, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Contour Fabricators of Florida, Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on June 25, 1996, 32 days after receiving the submission on May 24, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K962040 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1996
Decision Date June 25, 1996
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

Similar Devices — FMI Needle, Hypodermic, Single Lumen

All 684
Pen Needle
K252886 · Hh Global Technology, Inc. · Jan 2026
Pen Injector Needle 32.5
K250700 · Terumo Corporation · Nov 2025
Profoject? Disposable Needle
K252631 · CMT Health PTE., Ltd. · Oct 2025
Intraosseous Infusion Needles
K250724 · Spectrum Vascular · Jul 2025
TSK SELECT? Needle
K250284 · Tsk Laboratory, Japan · Jul 2025
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
K251447 · Terumo Europe N.V. · Jul 2025