GWYClass I

Pinwheel

21 CFR 882.1750 / Neurology

GWY is the FDA product code for Pinwheel, a class I device type, regulated under 21 CFR 882.1750. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2005-02-24, and no recalls.

Classification record

Product code: GWY
Device name: Pinwheel
Regulation: 21 CFR 882.1750
Device class: Class I
Review panel: Neurology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 0

Clearances, product code GWY

By decision year

5 clearances under product code GWY with a decision year between 1978 and 2005, 1978 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code GWY by decision year
Year	Clearances
1978	1
1985	1
1987	1
1994	1
2005	1

Applicants with the most clearances

Product code GWY

Applicants holding the most 510(k) clearances under product code GWY
Applicant	Clearances
Artiberia	1
Aspect Medical Systems, Inc.	1
Burke Neutech, Inc.	1
Dexin Pty., Ltd.	1
Projects in Health	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order

Recent clearances

Product code GWY

Recent recalls

Product code GWY

FDA records show no recalls under product code GWY.

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)