Cleared Traditional

K772292 - T-TUBE WHELAN-MOSS

K772292 is the FDA 510(k) clearance for T-TUBE WHELAN-MOSS by Davol, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCA) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K772292 · Davol, Inc. · Gastroenterology & Urology device
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Dec 1977
Decision
8d
Days
Class 2
Risk

K772292 is an FDA 510(k) clearance for the T-TUBE WHELAN-MOSS. 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. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977 after a review of 8 days - a notably fast clearance 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: 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 Davol, Inc. devices

Submission Details

510(k) Number K772292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1977
Decision Date December 20, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
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 K772292.
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K914755 · Davol, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
K915506 · United States Endoscopy Group, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOCATH
K911487 · United States Endoscopy Group, Inc. · Aug 1991