Cleared Traditional

K760927 - STOMA SHIELD ADAPTER

K760927 is an FDA 510(k) clearance for STOMA SHIELD ADAPTER, manufactured by Rudolfo T. Sanchez. The device is a Class 1 Gastroenterology & Urology device with product code EXE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K760927 · Rudolfo T. Sanchez · Gastroenterology & Urology device
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Jan 1977
Decision
90d
Days
Class 1
Risk

K760927 is an FDA 510(k) clearance for the STOMA SHIELD ADAPTER. Classified as Protector, Ostomy (product code EXE), Class I - General Controls.

Submitted by Rudolfo T. Sanchez (Mchenry, US). The FDA issued a Cleared decision on January 26, 1977 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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.

FDA 510(k) Submission Details - K760927

510(k) Number K760927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1976
Decision Date January 26, 1977
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EXE Device Classification - Class 1, General Controls

Product Code EXE Protector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
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.