Cleared Traditional

K961693 - DALE GASTROSTOMY TUBE HOLDER (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961693 · Dale Medical Products, Inc. · Gastroenterology & Urology device
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Jul 1996
Decision
90d
Days
Class 2
Risk

K961693 is an FDA 510(k) clearance for the DALE GASTROSTOMY TUBE HOLDER. Classified as Gastrointestional Tube Holder (product code PLI), Class II - Special Controls.

Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on July 30, 1996 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 876.5980 - 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 Dale Medical Products, Inc. devices

Submission Details

510(k) Number K961693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1996
Decision Date July 30, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLI Gastrointestional Tube Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Intended To Support, Secure, And Hold Gastrointestinal Tubes
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.