Cleared Traditional

1-125 ENDOSEED

K914825 · Endo Technic Corp. · Radiology
Mar 1992
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K914825 is an FDA 510(k) clearance for the 1-125 ENDOSEED, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Endo Technic Corp. (Omaha, US). The FDA issued a Cleared decision on March 19, 1992, 143 days after receiving the submission on October 28, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number K914825 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1991
Decision Date March 19, 1992
Days to Decision 143 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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

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