Cleared Traditional

WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET

K974118 · Worldwide Medical Technologies, LLC · Radiology
Jan 1998
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K974118 is an FDA 510(k) clearance for the WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET, a System, Applicator, Radionuclide, Manual (Class I — General Controls, product code IWJ), submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on January 23, 1998, 84 days after receiving the submission on October 31, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5650.

Submission Details

510(k) Number K974118 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1997
Decision Date January 23, 1998
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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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