Cleared Traditional

K871604 - MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS

K871604 is an FDA 510(k) clearance for MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS, manufactured by Advanced Surgical Products, Inc.. The device is a Class 2 Ophthalmic device with product code LXP cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K871604 · Advanced Surgical Products, Inc. · Ophthalmic device
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Jun 1987
Decision
49d
Days
Class 2
Risk

K871604 is an FDA 510(k) clearance for the MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS. Classified as Plug, Scleral (product code LXP), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Charles, US). The FDA issued a Cleared decision on June 12, 1987 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Surgical Products, Inc. devices

FDA 510(k) Submission Details - K871604

510(k) Number K871604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1987
Decision Date June 12, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 110d · This submission: 49d
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 K871604.
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
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
K854507 · Storz Instrument Co. · Feb 1986
SCLERAL PLUG
K831193 · Medical Instrument Development Laboratories, Inc. · Jun 1983