Cleared Traditional

K883605 - MODIFIED REUSABLE SITE FIBER OPTIC CABLE

K883605 is an FDA 510(k) clearance for MODIFIED REUSABLE SITE FIBER OPTIC CABLE, 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 63-day FDA review.

K883605 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Oct 1988
Decision
63d
Days
Class 2
Risk

K883605 is an FDA 510(k) clearance for the MODIFIED REUSABLE SITE FIBER OPTIC 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 October 25, 1988 after a review of 63 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 - K883605

510(k) Number K883605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date October 25, 1988
Days to Decision 63 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
47d faster than avg
Panel avg: 110d · This submission: 63d
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 K883605.
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
DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.
K883975 · Site Microsurgical Systems, Inc. · Oct 1988
NIDEK CV-4000
K880929 · Nidek, Inc. · May 1988
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
K881927 · Advanced Surgical Products, Inc. · May 1988