Cleared Traditional

K851960 - SOEHENDRA BILIARY DILATING CATHETER-SBDC-7

K851960 is an FDA 510(k) clearance for SOEHENDRA BILIARY DILATING CATHETER-SBDC-7, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K851960 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jul 1985
Decision
87d
Days
Class 2
Risk

K851960 is an FDA 510(k) clearance for the SOEHENDRA BILIARY DILATING CATHETER-SBDC-7. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 87 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 Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K851960

510(k) Number K851960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1985
Decision Date July 29, 1985
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K851960.
BARD-PARKER BILIARY BALLOON CATHETER
K852293 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
DAVOL RETRIEVAL BALLOON CATHETER
K853543 · C.R. Bard, Inc. · Sep 1985
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
K851242 · Cook, Inc. · Sep 1985
OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO
K851647 · Meadox Surgimed, Inc. · Jul 1985
VPDS-1 VENNES PANCREATIC DILATION SET
K851956 · Wilson-Cook Medical, Inc. · Jun 1985
BILIARY STENT PROSTHESIS
K844384 · Mentor Corp. · Feb 1985