LWIClass II

Ultrasound, Sinus

21 CFR 892.1560 / Radiology

LWI is the FDA product code for Ultrasound, Sinus, a class II device type, regulated under 21 CFR 892.1560. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 1997-04-16, and no recalls.

Classification record

Product code: LWI
Device name: Ultrasound, Sinus
Regulation: 21 CFR 892.1560
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: No
Ingested clearances: 4
Ingested recalls: 0

Clearances, product code LWI

By decision year

4 clearances under product code LWI with a decision year between 1987 and 1997, 1996 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code LWI by decision year
Year	Clearances
1987	1
1996	2
1997	1

Applicants with the most clearances

Product code LWI

Applicants holding the most 510(k) clearances under product code LWI
Applicant	Clearances
Custom Pack Reliability	1
Entlab Oy	1
Ferguson Medical	1
Pie Data Medical BV	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code LWI

Recent recalls

Product code LWI

FDA records show no recalls under product code LWI.

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)