Cleared Traditional

CRYOSTAT (K072414) - FDA 510(k) Clearance

K072414 · Lil Drug Store Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
223d
Days
-
Risk

K072414 is an FDA 510(k) clearance for the CRYOSTAT. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Lil Drug Store Products, Inc. (Cedar Rapids, US). The FDA issued a Cleared decision on April 7, 2008 after a review of 223 days - an extended review cycle.

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 K072414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2007
Decision Date April 07, 2008
Days to Decision 223 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 130d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -