510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993280Substantially Equivalent

Prostec 125I Brachytherapy Seeds

Prostec, LLC, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993280 is the FDA 510(k) clearance record for PROSTEC 125I BRACHYTHERAPY SEEDS, a class II device, cleared for Prostec, LLC on under FDA product code KXK (Source, Brachytherapy, Radionuclide). FDA records list 2 510(k) clearances for Prostec, LLC, from to . As of , FDA records show no recalls naming K993280.

Clearance record

Decision date
Received
(166 days to decision)
Product code
KXK Source, Brachytherapy, Radionuclide
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Prostec, LLC 19526 E. Lake Dr., Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code KXK

Trailing 12 months
1 clearance under product code KXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260