Cleared Traditional

K011191 - MEROCEL CORNELL LID AND LASH GUARD

K011191 is the FDA 510(k) clearance for MEROCEL CORNELL LID AND LASH GUARD by Medtronic Xomed, Inc.. It is a Class 2 Ophthalmic device (product code HOZ) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K011191 · Medtronic Xomed, Inc. · Ophthalmic device
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Jun 2001
Decision
68d
Days
Class 2
Risk

K011191 is an FDA 510(k) clearance for the MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 26, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4790 - 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 Medtronic Xomed, Inc. devices

Submission Details

510(k) Number K011191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date June 26, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 110d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HOZ Sponge, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4790
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 - HOZ Sponge, Ophthalmic

All 11
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K011191.
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · Deroyal Industries, Inc. · Sep 1997
VISI-SPEAR EYE SPONGE
K933872 · Visitec Co. · Dec 1993
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K910707 · Jedmed Instrument Co. · Apr 1991
VISI-SWAB OPHTALMIC SPONGE
K902750 · Visitec Co. · Jul 1990
VISI-SORB ABSORBANT STICK
K900786 · Visitec Co. · May 1990
VISITEC MICRO-SPONGE SPEARS
K896705 · Visitec Co. · Jan 1990