Cleared Traditional

K926217 - TERUMO ANGIOGRAPHIC CATHETER FOR LAPORO...

K926217 is an FDA 510(k) clearance for TERUMO ANGIOGRAPHIC CATHETER FOR LAPORO..., manufactured by Terumo Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBZ cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K926217 · Terumo Medical Corp. · General & Plastic Surgery device
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Jul 1993
Decision
215d
Days
Class 1
Risk

K926217 is an FDA 510(k) clearance for the TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 13, 1993 after a review of 215 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K926217

510(k) Number K926217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1992
Decision Date July 13, 1993
Days to Decision 215 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
100d slower than avg
Panel avg: 115d · This submission: 215d
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 15
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K926217.
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K944790 · Applied Medical Resources · Nov 1994
ENDOPATH
K942450 · Ethicon Endo-Surgery, Inc. · Aug 1994
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
K932228 · Boston Scientific Corp · Aug 1993
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
K924212 · Stryker Corp. · Jul 1993
ANGIOLAPCATH CHOLANGIOGRAPHY KIT
K926143 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1993
CHOLANGIOGRAPHY CLAMP
K924480 · Applied Medical Resources · Mar 1993