Cleared Traditional

K930297 - FUJINON VIDEO LAPAROSCOPE, MODIFIED (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K930297 · Fujinon, Inc. · General & Plastic Surgery device
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Mar 1994
Decision
432d
Days
Class 1
Risk

K930297 is an FDA 510(k) clearance for the FUJINON VIDEO LAPAROSCOPE, MODIFIED. Classified as Camera, Television, Endoscopic, Without Audio (product code FWF), Class I - General Controls.

Submitted by Fujinon, Inc. (New York, US). The FDA issued a Cleared decision on March 29, 1994 after a review of 432 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Fujinon, Inc. devices

Submission Details

510(k) Number K930297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date March 29, 1994
Days to Decision 432 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
318d slower than avg
Panel avg: 114d · This submission: 432d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWF Camera, Television, Endoscopic, Without 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.