PROSTEC 125I BRACHYTHERAPY SEEDS— 510(k) K993280

Substantially Equivalent

Prostec, LLC

FDA 510(k) clearance K993280 for PROSTEC 125I BRACHYTHERAPY SEEDS, Substantially Equivalent on 2000-03-14. Applicant: Prostec, LLC. Device class: 2.

Clearance details

Applicant: Prostec, LLC
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1999-09-30
Decision date: 2000-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXK

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

More clearances from Prostec, LLC

K001366 — PROSTEC 125I BRANCHYTHERAPY SNAPSEED2000-09-19

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