Cleared Traditional

K771429 - DISP. TEFLON CONNHCTOR (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K771429 · Quinton, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1977
Decision
143d
Days
Class 1
Risk

K771429 is an FDA 510(k) clearance for the DISP. TEFLON CONNHCTOR. Classified as Connector, Shunt (product code FJQ), Class I - General Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1977 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Quinton, Inc. devices

Submission Details

510(k) Number K771429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date December 22, 1977
Days to Decision 143 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
13d slower than avg
Panel avg: 130d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FJQ Connector, Shunt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5540
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.