Cleared Traditional

Rectal Applicator

K251037 · Nucletron B.V. · Radiology
Dec 2025
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K251037 is an FDA 510(k) clearance for the Rectal Applicator, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on December 19, 2025, 260 days after receiving the submission on April 3, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K251037 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2025
Decision Date December 19, 2025
Days to Decision 260 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

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