510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010166Substantially Equivalent

Imagyn Isosleeve / Isostar Needle System

Imagyn Medical Technologies, Inc., Richland MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010166 is the FDA 510(k) clearance record for IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM, a class I device, cleared for Imagyn Medical Technologies, Inc. on under FDA product code IWJ (System, Applicator, Radionuclide, Manual). FDA records list 7 510(k) clearances for Imagyn Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K010166.

Clearance record

Decision date
Received
(319 days to decision)
Product code
IWJ System, Applicator, Radionuclide, Manual
Regulation
21 CFR 892.5650
Device class
Class I
Review panel
Radiology
Applicant
Imagyn Medical Technologies, Inc. 8850 M-89, Richland MI
510(k) summary
Summary
Third party review
No

Clearances, product code IWJ

Trailing 12 months

FDA records hold no clearances under product code IWJ in the trailing twelve months.

FDA records show no clearances under product code IWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260