510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052228Substantially Equivalent

Smit Sleeve

Nucletron BV, Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052228 is the FDA 510(k) clearance record for SMIT SLEEVE, a class II device, cleared for Nucletron Corporation on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list 61 510(k) clearances for Nucletron Corporation, from to . As of , FDA records show no recalls naming K052228.

Clearance record

Decision date
Received
(85 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Nucletron Corporation 8671 Robert Fulton Dr., Columbia MD
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code JAQ

Trailing 12 months
4 clearances under product code JAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260