Cleared Traditional

K002596 - GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09

K002596 · Gebauer Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
178d
Days
-
Risk

K002596 is an FDA 510(k) clearance for the GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09. Classified as Vapocoolant Device (product code MLY).

Submitted by Gebauer Co. (Cleveland, US). The FDA issued a Cleared decision on February 15, 2001 after a review of 178 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

FDA 510(k) Submission Details - K002596

510(k) Number K002596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date February 15, 2001
Days to Decision 178 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
63d slower than avg
Panel avg: 115d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

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