Cleared Traditional

K771701 - VESSEL-CLUDE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K771701 · Med General · General & Plastic Surgery device
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Dec 1977
Decision
96d
Days
Class 1
Risk

K771701 is an FDA 510(k) clearance for the VESSEL-CLUDE. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Med General (Mchenry, US). The FDA issued a Cleared decision on December 13, 1977 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 K771701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1977
Decision Date December 13, 1977
Days to Decision 96 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
18d faster than avg
Panel avg: 114d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDJ Clamp, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.