Cleared Traditional

K862943 - SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE

K862943 is an FDA 510(k) clearance for SITE DISPOSABLE FIBEROPTIC ILLUMINATOR ..., manufactured by Site Microsurgical Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K862943 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Aug 1986
Decision
16d
Days
Class 2
Risk

K862943 is an FDA 510(k) clearance for the SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on August 21, 1986 after a review of 16 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 Site Microsurgical Systems, Inc. devices

FDA 510(k) Submission Details - K862943

510(k) Number K862943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date August 21, 1986
Days to Decision 16 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
94d faster than avg
Panel avg: 110d · This submission: 16d
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 K862943.
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
SERIES TEN THOUSAND MASTER
K861380 · CooperVision, Inc. · Jul 1986
SERIES TEN THOUSAND COMPACT
K861565 · CooperVision, Inc. · Jul 1986
I/A - VFE SYSTEM II
K854868 · Mira, Inc. · Feb 1986