BEST LOCALIZATION NEEDLE WITH I-125 SEED— 510(k) K122704

Name: FDA 510(k) clearance K122704
Creator: U.S. Food and Drug Administration
Published: 2013-01-09

Substantially Equivalent

Best Medical Intl.

FDA 510(k) clearance K122704 for BEST LOCALIZATION NEEDLE WITH I-125 SEED, Substantially Equivalent on 2013-01-09. Applicant: Best Medical Intl.. Device class: 2.

Clearance details

Applicant: Best Medical Intl.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2012-09-04
Decision date: 2013-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXK

view all

K252296 — OncoPatch2025-12-05
K242818 — IsoSphere2025-07-15
K223465 — RadianceTx Radionuclide Brachytherapy Source2023-01-11
K221539 — GammaTile2022-11-09
K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles2020-12-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.