Cleared Traditional

K924981 - OPERATIVE CHOLANGIOGRAM CATHETER

K924981 is an FDA 510(k) clearance for OPERATIVE CHOLANGIOGRAM CATHETER, manufactured by Taut, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBZ cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K924981 · Taut, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
187d
Days
Class 1
Risk

K924981 is an FDA 510(k) clearance for the OPERATIVE CHOLANGIOGRAM CATHETER. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Taut, Inc. (Geneva, US). The FDA issued a Cleared decision on April 6, 1993 after a review of 187 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Taut, Inc. devices

FDA 510(k) Submission Details - K924981

510(k) Number K924981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1992
Decision Date April 06, 1993
Days to Decision 187 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 115d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

GBZ Device Classification - Class 1, General Controls

Product Code GBZ Catheter, Cholangiography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.

Regulatory Peers - GBZ Catheter, Cholangiography

All 18
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K924981.
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
K924212 · Stryker Corp. · Jul 1993
ANGIOLAPCATH CHOLANGIOGRAPHY KIT
K926143 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1993
CLARUS CHOLANGIOGRAM CATHETER KIT
K925742 · Clarus Medical Systems, Inc. · Jun 1993
CHOLANGIOGRAPHY CLAMP
K924480 · Applied Medical Resources · Mar 1993
CHOLANGIOGRAPHY CATHETER
K924128 · Applied Medical Resources · Feb 1993
LAPAROSCOPIC SUCTION/IRRIGATION PROBE
K920643 · O.R. Concepts, Inc. · May 1992