Cleared Traditional

ICE BATON (K012746) - FDA 510(k) Clearance

K012746 · Behive, Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Nov 2001
Decision
90d
Days
-
Risk

K012746 is an FDA 510(k) clearance for the ICE BATON. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Behive, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on November 14, 2001 after a review of 90 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 K012746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2001
Decision Date November 14, 2001
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -