Cleared Traditional

K921091 - CHOLANGIOLAPCATH(TM)

K921091 is the FDA 510(k) clearance for CHOLANGIOLAPCATH(TM) by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 General & Plastic Surgery device (product code GBZ) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K921091 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery device
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May 1992
Decision
61d
Days
Class 1
Risk

K921091 is an FDA 510(k) clearance for the CHOLANGIOLAPCATH(TM). Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 6, 1992 after a review of 61 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K921091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1992
Decision Date May 06, 1992
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 12
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K921091.
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
CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP
K914015 · Pilling Co. · Nov 1991
MENTOR DUCTAL CATHETERS
K895285 · Mentor Corp. · Oct 1989
ATRIUM THORACIC CATHETER
K831931 · Atrium Medical Corp. · Oct 1983