Cleared Traditional

K130117 - NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS

K130117 is an FDA 510(k) clearance for NETWORK EYE SPEARS, manufactured by Network Medical Products, Ltd.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K130117 · Network Medical Products, Ltd. · Ophthalmic device
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Oct 2013
Decision
286d
Days
Class 2
Risk

K130117 is an FDA 510(k) clearance for the NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Network Medical Products, Ltd. (Ripon, GB). The FDA issued a Cleared decision on October 29, 2013 after a review of 286 days - an extended review 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: 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 Network Medical Products, Ltd. devices

FDA 510(k) Submission Details - K130117

510(k) Number K130117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2013
Decision Date October 29, 2013
Days to Decision 286 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
176d slower than avg
Panel avg: 110d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HOZ Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K130117.
SUNTOUCH EYE SPEAR
K132796 · Huizhou Foryou Medical Devices Co., Ltd. · Oct 2013
ULTRACELL ABSORBENT STICK
K012196 · Ultracell Medical Technologies, Inc. · Aug 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · Medtronic Xomed, Inc. · Jun 2001
ULTRACELL SUCTION SPONGE
K972633 · Ultracell Medical Technologies, Inc. · Dec 1997
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · Deroyal Industries, Inc. · Sep 1997
SURGI-WIPE
K942642 · Surgin Surgical Instrumentation, Inc. · Jul 1994