Cleared Traditional

K894570 - UNIVERSAL LIGHT CABLE

K894570 · Expanded Optics, Inc. · General & Plastic Surgery device
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Oct 1989
Decision
84d
Days
-
Risk

K894570 is an FDA 510(k) clearance for the UNIVERSAL LIGHT CABLE.

Submitted by Expanded Optics, Inc. (Westminster, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Expanded Optics, Inc. devices

FDA 510(k) Submission Details - K894570

510(k) Number K894570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1989
Decision Date October 13, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 24
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DISPOS. POLY APRONS
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