Cleared Traditional

K972633 - ULTRACELL SUCTION SPONGE

K972633 is an FDA 510(k) clearance for ULTRACELL SUCTION SPONGE, manufactured by Ultracell Medical Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K972633 · Ultracell Medical Technologies, Inc. · Ophthalmic device
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Dec 1997
Decision
156d
Days
Class 2
Risk

K972633 is an FDA 510(k) clearance for the ULTRACELL SUCTION SPONGE. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 156 days - an extended review 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: 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 Ultracell Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K972633

510(k) Number K972633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date December 17, 1997
Days to Decision 156 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
46d slower than avg
Panel avg: 110d · This submission: 156d
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 K972633.
SOF-SUCTION FLUID EVACUATION SYSTEM
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DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
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IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
K971832 · M-Pact Worldwide Management Corp. · Jul 1997
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K964855 · Shippert Medical Technologies Corp. · Mar 1997