Cleared Traditional

K930915 - FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE

K930915 · Gebauer Co. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
583d
Days
-
Risk

K930915 is an FDA 510(k) clearance for the FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE. Classified as Vapocoolant Device (product code MLY).

Submitted by Gebauer Co. (Washington, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 583 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

FDA 510(k) Submission Details - K930915

510(k) Number K930915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date September 29, 1994
Days to Decision 583 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
467d slower than avg
Panel avg: 116d · This submission: 583d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -
K930915 · FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE
Download PDF FDA Summary Gebauer Co.