Cleared Traditional

K896705 - VISITEC MICRO-SPONGE SPEARS

K896705 is an FDA 510(k) clearance for VISITEC MICRO-SPONGE SPEARS, 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 44-day FDA review.

K896705 · Visitec Co. · Ophthalmic device
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Jan 1990
Decision
44d
Days
Class 2
Risk

K896705 is an FDA 510(k) clearance for the VISITEC MICRO-SPONGE SPEARS. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 44 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 Visitec Co. devices

FDA 510(k) Submission Details - K896705

510(k) Number K896705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date January 11, 1990
Days to Decision 44 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 110d · This submission: 44d
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 12
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K896705.
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
ALCON SURGICAL SPONGE
K896004 · Alcon Laboratories · Nov 1989
FLUID DRAINAGE WICK
K885232 · Visitec Co. · Feb 1989
AMPCO OPTHALMIC TRAY
K842983 · Associated Medical Products Co. · May 1985