Cleared Traditional

MEDICOOL PROTECTALL (K934703) - FDA 510(k) Clearance

K934703 · Avc Regulatory Compliance/Technical Services · General & Plastic Surgery device
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Jan 1994
Decision
118d
Days
-
Risk

K934703 is an FDA 510(k) clearance for the MEDICOOL PROTECTALL.

Submitted by Avc Regulatory Compliance/Technical Services (New Hampton, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 K934703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1993
Decision Date January 26, 1994
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -