Cleared Traditional

K973590 - HEMORRELIEF DEVICE (FDA 510(k) Clearance)

K973590 · A.Stein - Regulatory Affairs Consulting · Gastroenterology & Urology device
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Feb 1998
Decision
136d
Days
-
Risk

K973590 is an FDA 510(k) clearance for the HEMORRELIEF DEVICE. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by A.Stein - Regulatory Affairs Consulting (Ginot Shomron 44853, IL). The FDA issued a Cleared decision on February 5, 1998 after a review of 136 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 K973590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1997
Decision Date February 05, 1998
Days to Decision 136 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
6d slower than avg
Panel avg: 130d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -