Cleared Traditional

READI-STRAND, MODEL PSSTRAND

K023179 · Worldwide Medical Technologies, LLC · Radiology
Jul 2003
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K023179 is an FDA 510(k) clearance for the READI-STRAND, MODEL PSSTRAND, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on July 2, 2003, 281 days after receiving the submission on September 24, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number K023179 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2002
Decision Date July 02, 2003
Days to Decision 281 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KXK — Source, Brachytherapy, Radionuclide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5730

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