Cleared Traditional

READI-STRAND, MODEL PSSTRAND

K022705 · Worldwide Medical Technologies, LLC · Radiology
Jun 2003
Decision
299d
Days
Class 2
Risk

About This 510(k) Submission

K022705 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 June 9, 2003, 299 days after receiving the submission on August 14, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number K022705 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2002
Decision Date June 09, 2003
Days to Decision 299 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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