Cleared Traditional

K895674 - MEDICOOL

K895674 · Medicool, Inc. · General & Plastic Surgery device
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Jan 1990
Decision
113d
Days
-
Risk

K895674 is an FDA 510(k) clearance for the MEDICOOL, CONTAINER FOR STORING INSULIN.

Submitted by Medicool, Inc. (Orange, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 113 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 K895674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date January 11, 1990
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 17
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