Cleared Traditional

K884556 - DREYER CURVED ENDOILLUMINATOR

K884556 is the FDA 510(k) clearance for DREYER CURVED ENDOILLUMINATOR by Advanced Surgical Products, Inc.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K884556 · Advanced Surgical Products, Inc. · Ophthalmic device
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Feb 1989
Decision
120d
Days
Class 2
Risk

K884556 is an FDA 510(k) clearance for the DREYER CURVED ENDOILLUMINATOR. 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 February 28, 1989 after a review of 120 days - within the typical 510(k) review window.

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: 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 Advanced Surgical Products, Inc. devices

Submission Details

510(k) Number K884556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1988
Decision Date February 28, 1989
Days to Decision 120 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
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K884556.
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
K894278 · Storz Instrument Co. · Aug 1989
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K884557 · Advanced Surgical Products, Inc. · May 1989
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K890300 · CooperVision, Inc. · Apr 1989
NIDEK CV-4000
K880929 · Nidek, Inc. · May 1988
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
K881927 · Advanced Surgical Products, Inc. · May 1988
SERIES TEN THOUSAND OCUTOME
K871871 · CooperVision, Inc. · Jun 1987