Cleared Traditional

K883984 - HEMORX COLD PACK (FDA 510(k) Clearance)

K883984 · Bio-Dyne, Inc. · Gastroenterology & Urology device
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Dec 1988
Decision
93d
Days
-
Risk

K883984 is an FDA 510(k) clearance for the HEMORX COLD PACK. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Bio-Dyne, Inc. (Miami, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 93 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 K883984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date December 22, 1988
Days to Decision 93 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 130d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -