510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LXPClass II

Plug, Scleral

21 CFR 886.4155 / Ophthalmic
FDA source (opens on fda.gov)

LXP is the FDA product code for Plug, Scleral, a class II device type, regulated under 21 CFR 886.4155. FDA's definition for this code reads: "Intended to provide temporary closure of a scleral incision during an ophthalmic procedure". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LXP
Device name
Plug, Scleral
FDA definition
Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
Regulation
21 CFR 886.4155
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
0

Clearances, product code LXP

By decision year
10 clearances under product code LXP with a decision year between 1983 and 2003, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LXP by decision year
YearClearances
19831
19841
19861
19871
19882
19931
19951
19991
20031

Applicants with the most clearances

Product code LXP
Applicants holding the most 510(k) clearances under product code LXP
ApplicantClearances
Advanced Surgical Products, Inc.3
Innovative Surgical Products, Inc.1
Medical Instrument Development Laboratories, Inc.1
Microvision, Inc.1
O.R. Specialties, Inc.1
Ophthalmic Consultants, Inc.1
Storz Instrument Co.1
Visitec Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code