Cleared Traditional

K896754 - I/A HANDPIECE

K896754 is an FDA 510(k) clearance for I/A HANDPIECE, manufactured by Advanced Surgical Products, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K896754 · Advanced Surgical Products, Inc. · Ophthalmic device
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Jan 1990
Decision
42d
Days
Class 2
Risk

K896754 is an FDA 510(k) clearance for the I/A HANDPIECE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 Advanced Surgical Products, Inc. devices

FDA 510(k) Submission Details - K896754

510(k) Number K896754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1989
Decision Date January 11, 1990
Days to Decision 42 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
68d faster than avg
Panel avg: 110d · This submission: 42d
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 92
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K896754.
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
K910973 · Surgical Technologies, Inc. · Apr 1991
SITE DISPOSABLE CUTTER AND ACCESSORIES
K896943 · Site Microsurgical Systems, Inc. · Mar 1990
CONVERTER SYSTEM
K894248 · Mira, Inc. · Feb 1990
MULTI-USE I/A HANDPIECE
K896305 · Advanced Surgical Products, Inc. · Dec 1989
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
K894278 · Storz Instrument Co. · Aug 1989
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
K891601 · Mira, Inc. · May 1989