Cleared Traditional

K942642 - SURGI-WIPE

K942642 is an FDA 510(k) clearance for SURGI-WIPE, manufactured by Surgin Surgical Instrumentation, Inc.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K942642 · Surgin Surgical Instrumentation, Inc. · Ophthalmic device
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Jul 1994
Decision
42d
Days
Class 2
Risk

K942642 is an FDA 510(k) clearance for the SURGI-WIPE. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on July 15, 1994 after a review of 42 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 Surgin Surgical Instrumentation, Inc. devices

FDA 510(k) Submission Details - K942642

510(k) Number K942642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date July 15, 1994
Days to Decision 42 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
68d faster than avg
Panel avg: 110d · This submission: 42d
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 17
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K942642.
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
VISI-SPEAR EYE SPONGE
K933872 · Visitec Co. · Dec 1993
SURGICAL SPEARS
K923922 · Ultracell Medical Technologies, Inc. · Mar 1993
OPHTHALMIC SPONGES
K920354 · Ultracell Medical Technologies, Inc. · Aug 1992