Cleared Traditional

K851242 - GRECO-HARVEY SURFACTANT BONDED CATHETER...

K851242 is the FDA 510(k) clearance for GRECO-HARVEY SURFACTANT BONDED CATHETER... by Cook, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K851242 · Cook, Inc. · Gastroenterology & Urology device
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Sep 1985
Decision
197d
Days
Class 2
Risk

K851242 is an FDA 510(k) clearance for the GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook, Inc. (New Brunswick, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 197 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 Cook, Inc. devices

Submission Details

510(k) Number K851242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date September 11, 1985
Days to Decision 197 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
67d slower than avg
Panel avg: 130d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 300
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K851242.
ENDODYNAMICS SIEGEL THERAPUTIC STENT
K853666 · E-Z-Em, Inc. · Nov 1985
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
SOEHENDRA BILIARY DILATING CATHETER-SBDC-7
K851960 · Wilson-Cook Medical, Inc. · Jul 1985
VPDS-1 VENNES PANCREATIC DILATION SET
K851956 · Wilson-Cook Medical, Inc. · Jun 1985
BILIARY STENT PROSTHESIS
K844384 · Mentor Corp. · Feb 1985