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LXP — Plug, Scleral Class II

FDA Device Classification

Classification Details

Product Code
LXP
Device Class
Class II
Regulation Number
886.4155
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K022186microvisionSCLERAL PLUGS, 19 AND 20 GAUGEFebruary 26, 2003
K990872ophthalmic consultantsSCLERAL PLUGS, 19 AND 20 GAUGEJuly 13, 1999
K945114visitecVISITEC SCLERAL PLUGFebruary 23, 1995
K925671o.r. specialtiesDISPOSABLE SCLERAL PLUGSAugust 2, 1993
K880953advanced surgical productsADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUGMay 13, 1988
K880952advanced surgical productsPRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGSMay 13, 1988
K871604advanced surgical productsMVS 19 AND MVS 20 GAUGE SCLERAL PLUGSJune 12, 1987
K854507storz instrumentSTORZ MVS 19 & 20 GAUGE SCLERAL PLUGSFebruary 7, 1986
K840693innovative surgical productsDISPOSABLE SCLERAL GLOBE PLUGMay 22, 1984
K831193medical instrument development laboratoriesSCLERAL PLUGJune 30, 1983