Cleared Traditional

K972119 - MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (FDA 510(k) Clearance)

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

K972119 · Medovations, Inc. · Gastroenterology & Urology device
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Feb 1998
Decision
242d
Days
Class 2
Risk

K972119 is an FDA 510(k) clearance for the MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX). Classified as Bougie, Esophageal, And Gastrointestinal, Gastro-urology (product code FAT), Class II - Special Controls.

Submitted by Medovations, Inc. (Germantown, US). The FDA issued a Cleared decision on February 2, 1998 after a review of 242 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.

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Submission Details

510(k) Number K972119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1997
Decision Date February 02, 1998
Days to Decision 242 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
112d slower than avg
Panel avg: 130d · This submission: 242d
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.