Cleared Traditional

K982754 - EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K982754 · A.Stein - Regulatory Affairs Consulting · General & Plastic Surgery device
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Jan 1999
Decision
155d
Days
Class 1
Risk

K982754 is an FDA 510(k) clearance for the EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7.... Classified as Camera, Television, Endoscopic, Without Audio (product code FWF), Class I - General Controls.

Submitted by A.Stein - Regulatory Affairs Consulting (Ginot Shomron 44853, IL). The FDA issued a Cleared decision on January 8, 1999 after a review of 155 days - an extended review 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: 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.

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Submission Details

510(k) Number K982754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date January 08, 1999
Days to Decision 155 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
41d slower than avg
Panel avg: 114d · This submission: 155d
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.