Cleared Traditional

INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (K960173) - FDA 510(k) Clearance

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

K960173 · Gabriel Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
163d
Days
Class 2
Risk

K960173 is an FDA 510(k) clearance for the INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT. Classified as Bougie, Esophageal, And Gastrointestinal, Gastro-urology (product code FAT), Class II - Special Controls.

Submitted by Gabriel Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on June 27, 1996 after a review of 163 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - 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 Gabriel Medical, Inc. devices

Submission Details

510(k) Number K960173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date June 27, 1996
Days to Decision 163 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
33d slower than avg
Panel avg: 130d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAT Bougie, Esophageal, And Gastrointestinal, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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.