Cleared Traditional

K864035 - VES-10 INTRAOCULAR SCISSORS DRIVE

K864035 is an FDA 510(k) clearance for VES-10 INTRAOCULAR SCISSORS DRIVE, manufactured by Trek Medical Products, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K864035 · Trek Medical Products, Inc. · Ophthalmic device
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Dec 1986
Decision
60d
Days
Class 2
Risk

K864035 is an FDA 510(k) clearance for the VES-10 INTRAOCULAR SCISSORS DRIVE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Trek Medical Products, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 60 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 Trek Medical Products, Inc. devices

FDA 510(k) Submission Details - K864035

510(k) Number K864035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1986
Decision Date December 15, 1986
Days to Decision 60 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 110d · This submission: 60d
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 93
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K864035.
SERIES TEN THOUSAND OCUTOME
K871871 · CooperVision, Inc. · Jun 1987
SITE PERISTALTIC MODULE SYSTEM
K871375 · Site Microsurgical Systems, Inc. · May 1987
ASPIRATION REVERSAL CONTROL (ARC) MODULE
K870068 · Optical Micro Systems, Inc. · Feb 1987
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
K862943 · Site Microsurgical Systems, Inc. · Aug 1986
SERIES TEN THOUSAND MASTER
K861380 · CooperVision, Inc. · Jul 1986
SERIES TEN THOUSAND COMPACT
K861565 · CooperVision, Inc. · Jul 1986