Cleared Traditional

K921654 - MCLEAN-STOCK PERCUTANEOUS T-TUBE SET

K921654 is an FDA 510(k) clearance for MCLEAN-STOCK PERCUTANEOUS T-TUBE SET, manufactured by Cook, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K921654 · Cook, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
86d
Days
Class 2
Risk

K921654 is an FDA 510(k) clearance for the MCLEAN-STOCK PERCUTANEOUS T-TUBE SET. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 2, 1992 after a review of 86 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 Cook, Inc. devices

FDA 510(k) Submission Details - K921654

510(k) Number K921654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1992
Decision Date July 02, 1992
Days to Decision 86 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
45d faster than avg
Panel avg: 131d · This submission: 86d
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 K921654.
ERCP CANNULA
K924107 · United States Endoscopy Group, Inc. · Dec 1992
BARD BILIARY BALLOON DILATORS
K920361 · C.R. Bard, Inc. · Nov 1992
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K924451 · Interventional Therapeutics Corp. · Oct 1992
GIANTURCO-ROSCH BILIARY Z STENT
K921191 · Cook, Inc. · May 1992
ACKRAD ERCP CONTRAST DELIVERY SET
K915813 · Ackrad Laboratories · Mar 1992
URESIL FIXATION DEVICE
K914699 · Uresil Corp. · Feb 1992