IWFClass II

Needle, Isotope, Gold, Titanium, Platinum

21 CFR 892.5730 / Radiology

IWF is the FDA product code for Needle, Isotope, Gold, Titanium, Platinum, a class II device type, regulated under 21 CFR 892.5730. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: IWF
Device name: Needle, Isotope, Gold, Titanium, Platinum
Regulation: 21 CFR 892.5730
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code IWF.

Recent clearances

Product code IWF

FDA records hold no clearances under product code IWF.

Recent recalls

Product code IWF

Z-0857-05Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator. Firm received one complaint...Mick Radio Nuclear Instr Inc / initiated 2005-03-30 / 327 cartons; RECALL EXPANSION: 926 cartons

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)