Cleared Traditional

IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

K010166 · Imagyn Medical Technologies, Inc. · Radiology
Dec 2001
Decision
319d
Days
Class 1
Risk

About This 510(k) Submission

K010166 is an FDA 510(k) clearance for the IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM, a System, Applicator, Radionuclide, Manual (Class I — General Controls, product code IWJ), submitted by Imagyn Medical Technologies, Inc. (Richland, US). The FDA issued a Cleared decision on December 3, 2001, 319 days after receiving the submission on January 18, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5650.

Submission Details

510(k) Number K010166 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2001
Decision Date December 03, 2001
Days to Decision 319 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IWJ — System, Applicator, Radionuclide, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.5650

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