LXZClass I

Guard, Instrument

21 CFR 878.4800 / General, Plastic Surgery

LXZ is the FDA product code for Guard, Instrument, a class I device type, regulated under 21 CFR 878.4800. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1996-01-23, and no recalls.

Classification record

Product code: LXZ
Device name: Guard, Instrument
Regulation: 21 CFR 878.4800
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: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code LXZ

By decision year

2 clearances under product code LXZ with a decision year between 1984 and 1996, 1984 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code LXZ by decision year
Year	Clearances
1984	1
1996	1

Applicants with the most clearances

Product code LXZ

Applicants holding the most 510(k) clearances under product code LXZ
Applicant	Clearances
Devon Industries, Inc.	1
Sil-Med Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order

Recent clearances

Product code LXZ

Recent recalls

Product code LXZ

FDA records show no recalls under product code LXZ.

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)