Cleared Traditional

K140558 - PROCTIGARD (FDA 510(k) Clearance)

K140558 · Access Pharmaceuticals, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2014
Decision
133d
Days
-
Risk

K140558 is an FDA 510(k) clearance for the PROCTIGARD. Classified as Protective Coating, Mucoadhesive Application, For The Rectal Mucosa (product code PHN).

Submitted by Access Pharmaceuticals, Inc. (New York, US). The FDA issued a Cleared decision on July 16, 2014 after a review of 133 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.

View all Access Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K140558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2014
Decision Date July 16, 2014
Days to Decision 133 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
3d slower than avg
Panel avg: 130d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device Class -
Definition Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa.