FWEClass I

Camera, Television, Microsurgical, With Audio

21 CFR 878.4160 / General, Plastic Surgery

FWE is the FDA product code for Camera, Television, Microsurgical, With Audio, a class I device type, regulated under 21 CFR 878.4160. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: FWE
Device name: Camera, Television, Microsurgical, With Audio
Regulation: 21 CFR 878.4160
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
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 FWE.

Recent clearances

Product code FWE

FDA records hold no clearances under product code FWE.

Recent recalls

Product code FWE

Z-1188-2016Class IISupplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing...Richard Wolf Medical Instruments Corp. / initiated 2016-02-29 / 108 units

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)