Cleared Traditional

K933872 - VISI-SPEAR EYE SPONGE

K933872 is an FDA 510(k) clearance for VISI-SPEAR EYE SPONGE, manufactured by Visitec Co.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K933872 · Visitec Co. · Ophthalmic device
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Dec 1993
Decision
143d
Days
Class 2
Risk

K933872 is an FDA 510(k) clearance for the VISI-SPEAR EYE SPONGE. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on December 27, 1993 after a review of 143 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 Visitec Co. devices

FDA 510(k) Submission Details - K933872

510(k) Number K933872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1993
Decision Date December 27, 1993
Days to Decision 143 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
33d slower than avg
Panel avg: 110d · This submission: 143d
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 34
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K933872.
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
K964855 · Shippert Medical Technologies Corp. · Mar 1997
OPHTHALMIC SPONGES
K950241 · Oasis Medical, Inc. · Feb 1995
SURGI-WIPE
K942642 · Surgin Surgical Instrumentation, Inc. · Jul 1994
SURGICAL SPEARS
K923922 · Ultracell Medical Technologies, Inc. · Mar 1993
OPHTHALMIC SPONGES
K920354 · Ultracell Medical Technologies, Inc. · Aug 1992
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K910707 · Jedmed Instrument Co. · Apr 1991