Cleared Traditional

K172598 - Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE

K172598 · Itw Contamination Control Electronics · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
233d
Days
-
Risk

K172598 is an FDA 510(k) clearance for the Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthet.... Classified as Vapocoolant Device (product code MLY).

Submitted by Itw Contamination Control Electronics (Kennesaw, US). The FDA issued a Cleared decision on April 19, 2018 after a review of 233 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 Itw Contamination Control Electronics devices

FDA 510(k) Submission Details - K172598

510(k) Number K172598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2017
Decision Date April 19, 2018
Days to Decision 233 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
118d slower than avg
Panel avg: 115d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 14
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K172598.
Syringe Holder accessory
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Vapocoolshot Mist
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K190161 · Gebauer Company · May 2019
Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
K172028 · Gebauer Company · Oct 2017
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
K172203 · Nuance Medical, LLC · Oct 2017
Pain Freeze™, Medium Stream Spray, Model #2101
K162218 · Nuance Medical, LLC · Nov 2016