Cleared Traditional

CAVERNOSOMETRY MODULE FOR MENUET (K923117) - FDA 510(k) Clearance

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

K923117 · Dantec Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 1993
Decision
241d
Days
Class 2
Risk

K923117 is an FDA 510(k) clearance for the CAVERNOSOMETRY MODULE FOR MENUET. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on February 22, 1993 after a review of 241 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.1650 - 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 Dantec Medical, Inc. devices

Submission Details

510(k) Number K923117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1992
Decision Date February 22, 1993
Days to Decision 241 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
111d slower than avg
Panel avg: 130d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 49
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K923117.
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · B.Braun Medical, Inc. · Mar 1997
CONTRAST INJECTION LINES
K960674 · B.Braun Medical, Inc. · Sep 1996
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
K955381 · B.Braun Medical, Inc. · Feb 1996
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415 · C.R. Bard, Inc. · Jan 1990