Cleared Traditional

K082460 - CENEFOM PVA SURGICAL SPEAR

K082460 is an FDA 510(k) clearance for CENEFOM PVA SURGICAL SPEAR, manufactured by Longtek Scientific Co., Ltd.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K082460 · Longtek Scientific Co., Ltd. · Ophthalmic device
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Dec 2008
Decision
111d
Days
Class 2
Risk

K082460 is an FDA 510(k) clearance for the CENEFOM PVA SURGICAL SPEAR. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Longtek Scientific Co., Ltd. (Houston, US). The FDA issued a Cleared decision on December 15, 2008 after a review of 111 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K082460

510(k) Number K082460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2008
Decision Date December 15, 2008
Days to Decision 111 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 110d · This submission: 111d
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 40
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K082460.
SUNTOUCH EYE SPEAR
K132796 · Huizhou Foryou Medical Devices Co., Ltd. · Oct 2013
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
K130117 · Network Medical Products, Ltd. · Oct 2013
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
K091240 · Alphamed, Inc. · Oct 2009
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
PRESCOTT'S SURGICAL SPEAR
K003842 · Prescott'S, Inc. · Apr 2001
K082460 · CENEFOM PVA SURGICAL SPEAR
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