Product code LXP

Device name: Plug, Scleral
Medical specialty: Ophthalmic
Device class: 2
Regulation number: 886.4155
Review panel: OP
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K022186	SCLERAL PLUGS, 19 AND 20 GAUGE	Microvision, Inc.	2003-02-26
K990872	SCLERAL PLUGS, 19 AND 20 GAUGE	Ophthalmic Consultants, Inc.	1999-07-13
K945114	VISITEC SCLERAL PLUG	Visitec Co.	1995-02-23
K925671	DISPOSABLE SCLERAL PLUGS	O.R. Specialties, Inc.	1993-08-02
K880952	PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS	Advanced Surgical Products, Inc.	1988-05-13
K880953	ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG	Advanced Surgical Products, Inc.	1988-05-13
K871604	MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS	Advanced Surgical Products, Inc.	1987-06-12
K854507	STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS	Storz Instrument Co.	1986-02-07
K840693	DISPOSABLE SCLERAL GLOBE PLUG	Innovative Surgical Products, Inc.	1984-05-22
K831193	SCLERAL PLUG	Medical Instrument Development Laboratories, Inc.	1983-06-30

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