Cleared Traditional

ANOKRYO (K964634) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K964634 · Mk Conquest Intl., Inc. · Gastroenterology & Urology device
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Jun 1997
Decision
199d
Days
Class 1
Risk

K964634 is an FDA 510(k) clearance for the ANOKRYO. Classified as Dilator, Rectal (product code FFP), Class I - General Controls.

Submitted by Mk Conquest Intl., Inc. (Fort Worth, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 199 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5450 - the FDA gastroenterology and urology device framework. 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 Mk Conquest Intl., Inc. devices

Submission Details

510(k) Number K964634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1996
Decision Date June 06, 1997
Days to Decision 199 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
69d slower than avg
Panel avg: 130d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFP Dilator, Rectal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.