Cleared Traditional

GEBAUER'S INSTANT ICE (K021726) - FDA 510(k) Clearance

K021726 · Gebauer Co. · Physical Medicine device
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Dec 2002
Decision
202d
Days
-
Risk

K021726 is an FDA 510(k) clearance for the GEBAUER'S INSTANT ICE. Classified as Vapocoolant Device (product code MLY).

Submitted by Gebauer Co. (Cleveland, US). The FDA issued a Cleared decision on December 12, 2002 after a review of 202 days - an extended review cycle.

This device falls under the Physical Medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Gebauer Co. devices

Submission Details

510(k) Number K021726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2002
Decision Date December 12, 2002
Days to Decision 202 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 115d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 22
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