Cleared Traditional

COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (K113660) - FDA 510(k) Clearance

K113660 · Cryotherapy Products, Inc. · Gastroenterology & Urology device
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May 2012
Decision
142d
Days
-
Risk

K113660 is an FDA 510(k) clearance for the COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Cryotherapy Products, Inc. (Terrace Davie, US). The FDA issued a Cleared decision on May 3, 2012 after a review of 142 days - within the typical 510(k) review window.

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

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Submission Details

510(k) Number K113660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2011
Decision Date May 03, 2012
Days to Decision 142 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 130d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -