Cleared Traditional

K890544 - SHAPIRO CUTTER

K890544 is an FDA 510(k) clearance for SHAPIRO CUTTER, manufactured by H.S. Intl. Co., Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K890544 · H.S. Intl. Co., Inc. · Ophthalmic device
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Feb 1989
Decision
25d
Days
Class 2
Risk

K890544 is an FDA 510(k) clearance for the SHAPIRO CUTTER. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by H.S. Intl. Co., Inc. (Concord, US). The FDA issued a Cleared decision on February 28, 1989 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 H.S. Intl. Co., Inc. devices

FDA 510(k) Submission Details - K890544

510(k) Number K890544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1989
Decision Date February 28, 1989
Days to Decision 25 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 110d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 87
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K890544.
SURG-E-TROL SYSTEM I AND SYSTEM II
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DREYER CURVED ENDOILLUMINATOR
K884556 · Advanced Surgical Products, Inc. · Feb 1989
LASER INDIRECT OPHTHALMOSCOPE (LIO)
K885196 · Coherent Medical Group · Jan 1989
.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.
K883926 · Site Microsurgical Systems, Inc. · Nov 1988
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K883605 · Site Microsurgical Systems, Inc. · Oct 1988