Cleared Traditional

MED. DYNAMICS SATICAN VIDEO CAMERA 5410 (K843294) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K843294 · Medline Industries, Inc. · General & Plastic Surgery device
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Dec 1984
Decision
113d
Days
Class 1
Risk

K843294 is an FDA 510(k) clearance for the MED. DYNAMICS SATICAN VIDEO CAMERA 5410. Classified as Camera, Surgical And Accessories (product code KQM), Class I - General Controls.

Submitted by Medline Industries, Inc. (Englewood, US). The FDA issued a Cleared decision on December 12, 1984 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K843294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1984
Decision Date December 12, 1984
Days to Decision 113 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQM Camera, Surgical And Accessories
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.