LXP · Class II · 21 CFR 886.4155

FDA Product Code LXP: Plug, Scleral

Intended To Provide Temporary Closure Of A Scleral Incision During An Ophthalmic Procedure.

Leading manufacturers include Advanced Surgical Products, Inc., Medical Instrument Development Laboratories, Inc. and Storz Instrument Co..

10
Total
10
Cleared
119d
Avg days
1983
Since

FDA 510(k) Cleared Plug, Scleral Devices (Product Code LXP)

10 devices
1–10 of 10
Cleared Jul 13, 1999
SCLERAL PLUGS, 19 AND 20 GAUGE
K990872
Ophthalmic Consultants, Inc.
Ophthalmic · 119d
Cleared Feb 23, 1995
VISITEC SCLERAL PLUG
K945114
Visitec Co.
Ophthalmic · 128d
Cleared May 13, 1988
PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
K880952
Advanced Surgical Products, Inc.
Ophthalmic · 67d
Cleared May 13, 1988
ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
K880953
Advanced Surgical Products, Inc.
Ophthalmic · 67d
Cleared Jun 12, 1987
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
K871604
Advanced Surgical Products, Inc.
Ophthalmic · 49d
Cleared Feb 07, 1986
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
K854507
Storz Instrument Co.
Ophthalmic · 87d
Cleared Jun 30, 1983
SCLERAL PLUG
K831193
Medical Instrument Development Laboratories, Inc.
Ophthalmic · 79d

About Product Code LXP - Regulatory Context