Cleared Traditional

K022186 - SCLERAL PLUGS

K022186 is an FDA 510(k) clearance for SCLERAL PLUGS, manufactured by Microvision, Inc.. The device is a Class 2 Ophthalmic device with product code LXP cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K022186 · Microvision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
236d
Days
Class 2
Risk

K022186 is an FDA 510(k) clearance for the SCLERAL PLUGS, 19 AND 20 GAUGE. Classified as Plug, Scleral (product code LXP), Class II - Special Controls.

Submitted by Microvision, Inc. (Seabrook, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 236 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4155 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Microvision, Inc. devices

FDA 510(k) Submission Details - K022186

510(k) Number K022186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2002
Decision Date February 26, 2003
Days to Decision 236 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 110d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXP Device Classification - Class 2, Special Controls

Product Code LXP Plug, Scleral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4155
Definition Intended To Provide Temporary Closure Of A Scleral Incision During An Ophthalmic Procedure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LXP Plug, Scleral

Devices cleared under the same product code (LXP) and FDA review panel - the closest regulatory comparables to K022186.
VISITEC SCLERAL PLUG
K945114 · Visitec Co. · Feb 1995
PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
K880952 · Advanced Surgical Products, Inc. · May 1988
ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
K880953 · Advanced Surgical Products, Inc. · May 1988
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
K871604 · Advanced Surgical Products, Inc. · Jun 1987
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
K854507 · Storz Instrument Co. · Feb 1986