Cleared Traditional

THERMA-H (K921189) - FDA 510(k) Clearance

K921189 · Zewa AG · Gastroenterology & Urology device
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Aug 1992
Decision
181d
Days
-
Risk

K921189 is an FDA 510(k) clearance for the THERMA-H. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Zewa AG (Miami, US). The FDA issued a Cleared decision on August 31, 1992 after a review of 181 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 K921189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1992
Decision Date August 31, 1992
Days to Decision 181 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
51d slower than avg
Panel avg: 130d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -