Cleared Traditional

BR-S601MU (SURGICAL VIDEO RECORDER) (K890119) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K890119 · Victor Co. of Japan, Ltd. C/O Jvc Corp. · General & Plastic Surgery device
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Jan 1989
Decision
13d
Days
Class 1
Risk

K890119 is an FDA 510(k) clearance for the BR-S601MU (SURGICAL VIDEO RECORDER). Classified as Camera, Television, Surgical, With Audio (product code FWC), Class I - General Controls.

Submitted by Victor Co. of Japan, Ltd. C/O Jvc Corp. (Elmwood Park, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - the FDA general and plastic surgery 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 Victor Co. of Japan, Ltd. C/O Jvc Corp. devices

Submission Details

510(k) Number K890119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1989
Decision Date January 24, 1989
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWC Camera, Television, Surgical, With Audio
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.