Cleared Traditional

K914755 - DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHET...

K914755 is the FDA 510(k) clearance for DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHET... by Davol, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCA) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K914755 · Davol, Inc. · Gastroenterology & Urology device
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Mar 1992
Decision
160d
Days
Class 2
Risk

K914755 is an FDA 510(k) clearance for the DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT. Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 160 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Davol, Inc. devices

Submission Details

510(k) Number K914755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 22, 1991
Decision Date March 30, 1992
Days to Decision 160 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 130d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 19
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K914755.
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
K931619 · Boston Scientific Corp · Aug 1993
BARD STONE REMOVAL BALLOON CATHETER
K920342 · C.R. Bard, Inc. · Aug 1992
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K915343 · Uresil Corp. · Mar 1992
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
K915506 · United States Endoscopy Group, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOCATH
K911487 · United States Endoscopy Group, Inc. · Aug 1991
T-TUBE WHELAN-MOSS
K772292 · Davol, Inc. · Dec 1977