Cleared Traditional

MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS (K871604) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.