Cleared Traditional

ENCOMPAS COMFORT BLOCK # 0B-10 (K933537) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K933537 · Encompas Unlimited, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
261d
Days
Class 1
Risk

K933537 is an FDA 510(k) clearance for the ENCOMPAS COMFORT BLOCK # 0B-10. Classified as Endoscopic Bite Block (product code MNK), Class I - General Controls.

Submitted by Encompas Unlimited, Inc. (Tierra Verde, US). The FDA issued a Cleared decision on April 8, 1994 after a review of 261 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Encompas Unlimited, Inc. devices

Submission Details

510(k) Number K933537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1993
Decision Date April 08, 1994
Days to Decision 261 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
131d slower than avg
Panel avg: 130d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNK Endoscopic Bite Block
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
Definition To Prevent Patient From Biting Down In Order To Protect Fragile Endoscope Equipment, Patient's Teeth And Gums, And Endscopist's Fingers When Inserting Endoscope Orally.
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.