Cleared Traditional

K974313 - HYDROFERA SURGICAL SPEAR

K974313 is an FDA 510(k) clearance for HYDROFERA SURGICAL SPEAR, manufactured by Hydrofera, LLC. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K974313 · Hydrofera, LLC · Ophthalmic device
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Mar 1998
Decision
105d
Days
Class 2
Risk

K974313 is an FDA 510(k) clearance for the HYDROFERA SURGICAL SPEAR. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on March 2, 1998 after a review of 105 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.

View all Hydrofera, LLC devices

FDA 510(k) Submission Details - K974313

510(k) Number K974313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date March 02, 1998
Days to Decision 105 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 110d · This submission: 105d
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 13
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K974313.
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · Medtronic Xomed, Inc. · Jun 2001
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