Cleared Traditional

K261684 - FreezeSpray TA

K261684 · Cryosurgery, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
107d
Days
-
Risk

K261684 is an FDA 510(k) clearance for the FreezeSpray TA. Classified as Vapocoolant Device (product code MLY).

Submitted by Cryosurgery, Inc. (Nashville, US). The FDA issued a Cleared decision on September 5, 2026 after a review of 107 days - within the typical 510(k) review window.

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 Cryosurgery, Inc. devices

FDA 510(k) Submission Details - K261684

510(k) Number K261684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2026
Decision Date September 05, 2026
Days to Decision 107 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
9d faster than avg
Panel avg: 116d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 19
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K261684.
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PainFreeze II
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CRYO Arctic, CRYO Penguin
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num Vapocoolant
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