Cleared Traditional

PERI-COMFORT(TM) SEATING CUSHION (K932396) - FDA 510(k) Clearance

K932396 · Chi'Am Intl. · Gastroenterology & Urology device
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Sep 1993
Decision
135d
Days
-
Risk

K932396 is an FDA 510(k) clearance for the PERI-COMFORT(TM) SEATING CUSHION. Classified as Cushion, Hemorrhoid (product code LRL).

Submitted by Chi'Am Intl. (Circle Pines, US). The FDA issued a Cleared decision on September 30, 1993 after a review of 135 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 K932396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date September 30, 1993
Days to Decision 135 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
5d slower than avg
Panel avg: 130d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRL Cushion, Hemorrhoid
Device Class -